The Effect of Pasak Bumi (Eurycoma longifolia, Jack) Roots Ethanol Extract against Hematology Profile of Healthy Volunteers

The roots of Eurycoma longifolia, Jack has a lot of beneficial activity on human health. The use of Eurycoma longifolia, Jack roots as a traditional medicine should be made in the form of a dosage that is more effective, safe, and had no side effects, especially on hematology. Easy preparations are capsule. This study aimed at identifying the effect of ethanol extract capsule of Eurycoma longifolia, Jack roots on hematology of healthy volunteers. Healthy volunteers were assigned in the study, each of which were 10 male and 10 female who met the inclusion criteria. Both groups were given ethanol extract capsule of Eurycoma longifolia, Jack roots for 14 days, with the dose of 300 mg extract once a day, after meal, at night. Hematology examination was performed on day 0; 14 and 42. Results were compared statistically using Repeated ANOVA and Friedman tests. The result of the study indicated that the average value of hematology at the examination day of 0; 14; and 42, there were significant differences in MCV and leukocyte parameters in healthy male volunteers (p<0.05). MCH, LED and monocyte parameters in healthy female volunteers had a significant difference of (p<0.05). However, the parameter values were still within the normal range. Monitoring results showed that some of the side effects were frequent urinary, dizziness, nausea, sweating, insomnia, and increasing appetite on healthy male volunteers. Meanwhile, on healthy female volunteers, there were frequent urinary, insomnia, constipation. Having ethanol extract capsule of the Eurycoma longifolia, Jack roots did not affect the hematology parameters of healthy male and female volunteers, but it caused some side effects.

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Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency

Journal of Opioid Management ◽

10.5055/jom.2015.0270 ◽

2015 ◽

Vol 11 (3) ◽

pp. 211 ◽

Cited By ~ 23

Author(s):

Gary Eichenbaum, PhD ◽

Karin Göhler, MD ◽

Mila Etropolski, MD ◽

Ilona Steigerwald, MD, PhD ◽

Joseph Pergolizzi, MD ◽

...

Keyword(s):

Single Dose ◽

Medical Research ◽

Healthy Volunteers ◽

Opioid Analgesics ◽

Sex Hormone ◽

Androgen Deficiency ◽

Research Centers ◽

Healthy Male ◽

Healthy Male Volunteers ◽

Male Volunteers

Objectives: Opioid-induced androgen deficiency (OPIAD) affects patients treated with opioid analgesics. The norepinephrine reuptake inhibitor (NRI) and μ-opioid receptor (MOR) agonist activities of tapentadol may result in tapentadol having less effect on serum androgen concentrations than analgesics acting through the MOR alone, such as morphine and oxycodone. The objectives of this publication are to 1) evaluate the effects of tapentadol (NUCYNTA and NUCYNTA extended release [ER]) on sex hormone concentrations in healthy male volunteers (vs placebo and morphine) and patients with osteoarthritis (vs placebo and oxycodone), and 2) present a mechanistic hypothesis explaining how the combined MOR agonist and NRI activities of tapentadol may result in less impact on androgen concentrations. Methods: Three clinical studies were conducted: study 1 (single-dose comparison study vs morphine in healthy volunteers), study 2 (single-dose-escalation study in healthy volunteers without an active comparator), and study 3 (multiple-dose study vs oxycodone in patients with osteoarthritis). Studies 1 and 2 were conducted at medical research centers in Germany and the United Kingdom; study 3 was conducted at primary and secondary care centers and medical research centers in the United States. All three studies were randomized, double blind, and placebo controlled. Concentrations of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH; study 3 only) were evaluated at 6 and 24 hours postdose in studies 1 and 2, respectively, and at varying time points postdose in study 3.Results: In study 1, mean serum total testosterone concentrations in healthy male volunteers were similar at baseline for all treatment periods; 6 hours after dosing, mean concentrations were comparable between placebo (8.6 nmol/L) and tapentadol immediate release (IR; 43 mg, 8.8 nmol/L; 86 mg, 9.3 nmol/L), but were lower following administration of morphine IR 30 mg (5.4 nmol/L). In study 2, there were no or minimal changes in testosterone in the therapeutic dose range with tapentadol IR (75-100 mg), and there was a modest decrease that appeared to level off in the supratherapeutic range (125-175 mg); mean testosterone and LH concentrations with all doses remained within normal ranges (testosterone, 4.56-28.2 nmol/L; LH, 2.9-4.6 U/L). In study 3, the decrease in the mean [standard deviation] testosterone concentration from baseline to endpoint for male patients receiving tapentadol ER (100 mg, −1.9 [0.71] nmol/L; 200 mg, −2.1 [0.93] nmol/L) was numerically smaller compared to oxycodone CR (20 mg, −2.7 [0.93] nmol/L), but higher compared to placebo (−0.3 [1.62] nmol/L).Conclusions: These results suggest that tapentadol, which has combined MOR and NRI activities, may have a lower impact on sex hormone concentrations than pure opioid analgesics, such as morphine or oxycodone. The data and mechanistic rationale presented herein provide a justification for conducting additional hypothesis testing studies, and are not intended to be used as a basis for clinical decision making. Future studies may help elucidate whether the observed trends are clinically significant and would translate into a reduced incidence of OPIAD.

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Pharmacokinetic Parameters of Ciprofloxacin in Bangladeshi Volunteers: A Preliminary Evaluation

Bangladesh Journal of Physiology and Pharmacology ◽

10.3329/bjpp.v27i1-2.20066 ◽

2014 ◽

Vol 27 (1-2) ◽

pp. 1-8

Author(s):

Reefat Zaman Chowdhury ◽

Md Saiful Islam ◽

Md Sayedur Rahman

Keyword(s):

Healthy Volunteers ◽

Oral Route ◽

Absolute Bioavailability ◽

Pharmacokinetic Parameters ◽

Intravenous Route ◽

Population Pharmacokinetic ◽

Healthy Male ◽

Healthy Male Volunteers ◽

Male Volunteers ◽

The Difference

The present study has attempted to establish a High-performance liquid chromatography (HPLC) method to determine ciprofloxacin in plasma, in order to evaluate the bioavailability of ciprofloxacin. In this study, initially 8 (eight) Bangladeshi Bangalee healthy male volunteers and 7 (seven) Bangladeshi Tribal healthy male volunteers received 500 mg tablet of pioneer brand of ciprofloxacin in oral route. Blood samples were collected at 0, 30, 60, 120, 180, 360, 540 and 720 minutes after drug administration. After 1 week of washout period, same volunteers of two groups received 200 mg injection of pioneer brand of ciprofloxacin in intravenous route. HPLC with ultraviolet detection was used to quantify plasma ciprofloxacin concentrations. In case of oral route, AUC012h, Cmax, Tmax and T1/2 values for Bangladeshi Bangalee and Tribal healthy volunteers were 545.53 ± 32.35 & 655.74 ± 16.57 ?g min/mL, 2.19 ± 0.16 & 2.49 ± 0.20 ?g/mL, 75.00 ± 27.77 & 94.29 ± 32.07 min and 241.96 ± 13.53 & 242.02 ± 19.88 min respectively. In case of intravenous route, the AUC012h, Cmax, Tmax and T1/2 values for Bangladeshi Bangalee and Tribal healthy volunteers were 344.07 ± 29.31 & 343.31 ± 25.34 ?g min/mL, 2.47 ± 0.17 & 2.46 ± 0.18 ?g/mL, 30.00 ± 0.00 & 30.0 ± 0.0 min and 278.16 ± 1.74 & 272.74 ± 4.42 min respectively and the difference between these two groups of volunteers was not significant. The difference in AUC012h, Cmax, Tmax and T1/2 values between these two groups of volunteers was significant. The mean percent absolute bioavailability in Bangladeshi Bangalee and Tribal healthy volunteers was 64.04 ± 3.21 and 76.81 ± 6.71 respectively. In conclusion, pharmacokinetic parameters of ciprofloxacin significantly varied among Bangladeshi Bangalee and Bangladeshi Tribal healthy volunteers indicating necessity of further study on population pharmacokinetic in these groups of people. DOI: http://dx.doi.org/10.3329/bjpp.v27i1-2.20066 Bangladesh J Physiol Pharmacol 2011;27(1&2):1-8.

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Effect of Ranitidine on the Pharmacokinetics of Orally Administered Eprosartan, an Angiotensin II Antagonist, in Healthy Male Volunteers

Annals of Pharmacotherapy ◽

10.1345/aph.17188 ◽

1998 ◽

Vol 32 (3) ◽

pp. 304-308 ◽

Cited By ~ 7

Author(s):

David M Tenero ◽

David E Martin ◽

Bernard E Ilson ◽

Duane A Boyle ◽

Steven C Boike ◽

...

Keyword(s):

Oral Dose ◽

Treatment Session ◽

Healthy Male ◽

Open Label ◽

Healthy Male Volunteers ◽

Male Volunteers ◽

Significant Difference ◽

Angiotensin Ii Antagonist ◽

Repeated Doses ◽

Quantifiable Concentration

OBJECTIVE: To assess the effect of ranitidine on the pharmacokinetics of eprosartan in healthy male volunteers. DESIGN: Single-center, randomized, open-label, two-period, period-balanced, crossover study. PATIENTS: Seventeen healthy men aged 19 to 43 years. INTERVENTION: In each period (separated by a ≥7 d washout), subjects received a single 400-mg oral dose of eprosartan alone, or a single oral dose of eprosartan 400 mg and ranitidine 150 mg on day 4 after 3 days of ranitidine 150 mg twice daily. Serial pharmacokinetic samples were obtained for up to 24 hours following eprosartan dosing. MAIN OUTCOME MEASURES: Plasma and urine eprosartan concentrations during each treatment session. RESULTS: Eprosartan maximum concentration (Cmax), the AUC from time zero to the last quantifiable concentration (AUC0-t), and renal clearance (Clr) values were approximately 7%, 11%, and 4% lower, respectively, when administered with ranitidine compared with eprosartan alone. The 95% CIs for the ratio of eprosartan plus ranitidine compared with eprosartan alone were 0.81 to 1.07, 0.77 to 1.03, and 0.64 to 1.43, for Cmax, AUC0-t, and Clr, respectively, indicating no statistically significant difference between regimens. CONCLUSIONS: Repeated doses of ranitidine did not have a marked effect on the single-dose pharmacokinetics of eprosartan. OBJETIVO: Evaluar el efecto de ranitidina en la farmacocinética de eprosartan en pacientes voluntarios saludables. DISEÑO: Centro sencillo, estudio randomizado, rotulación abierta, dos períodos, período cruzado balanceado. PACIENTES: Díecisiete hombres saludables entre 19 a 43 años. INTERVENCIÓN: En cada período (separado por 7 d o más sín medicamento), los pacientes recibieron una dosis oral de eprosartan 400 mg solamente, o una dosis oral eprosartan 400 mg y ranitidina 150 mg 2 veces al día. Muestras en serie sobre la farmacocinética fueron obtenidas hasta 24 horas después de la dosis de eprosartan. MEDICIÓN DE RESULTADOS: Concentraciones en plasma y orina de eprosartan durante cada período de tratamiento. RESULTADOS: Los valores promedio de concentración máxima (Cmax), ABC0-t, y depuración renal (Clr) de eprosartan fueron aproximadamente 7%, 11%, y 4% más bajo, respectivamente, comparado con eprosartan sólo. En intervalos de un 95% de confianza, la razón de eprosartan y ranitidina comparado con eprosartan sólo fueron 0.81 a 1.07, 0.77 a 1.03, y 0.64 a 1.43 para Cmax, ABC0-t, y Clr, respectivamente, indicando que no hay diferencia estadística entre ambos régimenes. CONCLUSIONES: Dosis repetidas de ranitidina no producen un efecto marcado en la farmacocinética de eprosartan en dosis sencillas. OBJECTIF: Évaluer l'effet de la ranitidine sur la pharmacocinétique de l'éprosartan chez des volontaires sains. DEVIS EXPÉRIMENTAL: Étude à échantillonagealéatoire, ouverte, en chassécroisé comprenant deux périodes, et réalisée dans un seul établissement. PATIENTS: Dix-sept hommes sains, âgés entre 19 et 43 ans. INTERVENTION: Dans chaque période (séparée par 7 j de sevrage thérapeutique), les volontaires reçurent soit une dose unique de 400 mg d'éprosartan, ou une dose unique de 400 mg d'éprosartan et 150 mg de ranitidine au jour 4, suivant l'administration de 150 mg de ranitidine aux 12 heures les 3 premiers jours. Plusieurs échantillons pharmacocinétiques furent obtenus durant les 24 heures suivant l'administration d'éprosartan. MESURES DE L'ÉFFET: Concentrations urinaires et plasmatiques d'éprosartan durant chacune des deux périodes de traitement. RÉSULTATS: Quand l'éprosartan fut administré avec la ranitidine, la concentration maximale, la surface sous la courbe, et la clairance rénale d'éprosartan étaient en moyenne approximativement 7%, 11%, et 4% inférieures, respectivement, aux valeurs obtenues avec l'éprosartan administré seul. Aucune différence statistiquement significative n'a été observée entre l'éprosartan administré avec la ranitidine et l'éprosartan seul. Les intervalles de confiance à 95% pour les rapports des valeurs entre les deux groupes sont pour la concentration maximale 0.81 à 1.07, la surface sous la courbe 0.77 à 1.03, et la clairance rénale 0.64 à 1.43. CONCLUSIONS: L'administration de doses répétées de ranitidine n'a pas démontré d'effet marqué sur la pharmacocinétique d'une dose unique d'éprosartan.

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The effect of ethanol extract of pasak bumi (Eurycoma longifolia Jack.) on neurogenesis and neuroinflammation of rat post protein malnutrition

IOP Conference Series Earth and Environmental Science ◽

10.1088/1755-1315/913/1/012091 ◽

2021 ◽

Vol 913 (1) ◽

pp. 012091

Author(s):

D D Sanyoto ◽

Triawanti ◽

M S Noor

Keyword(s):

Ethanol Extract ◽

Protein Malnutrition ◽

Elisa Method ◽

Bdnf Level ◽

Ginseng Extract ◽

Eurycoma Longifolia ◽

Significant Difference ◽

Eurycoma Longifolia Jack ◽

The Mean ◽

The Brain

Abstract Protein malnutrition may affect changes in morphology, neurochemistry, neurogenesis and immune system in the brain. Pasak bumi is often used as an aphrodisiac which is almost the same as Ginseng. The neurogenesis development can be stimulated by ginseng extract intervention. This study aimed to prove the effect of pasak bumi on neurogenesis and neuroinflammation in post-protein malnutrition rats. Experimental research design, rats were divided into 6 groups: KN=normal rats+standard feed, P1=malnutrition rats+aquadest, P2=malnutrition rats + 70% ethanol extract of pasak bumi (EPB) 7.5 mg/kg BW, P3=malnutrition rats + EPB 15 mg/kg BW, P4=malnutrition rats + EPB 22.5 mg/kg BW, P5=malnutrition rats + EPB 30 mg/kg BW. EPB administration for 5 weeks. Parameters examined were levels of BDNF, IL6, TNFα, and serotonin by ELISA method. Statistical analysis using ANOVA and Kruskal Wallis test with 95% confidence level. The results of the study: the mean BDNF level in the P3 group was significantly highest (p=0.047). However, there was no significant difference between groups in IL6, TNFα, and serotonin. Conclusion: The 70% ethanol extract of pasak bumi did not affect neuroinflammation and brain serotonin levels in post-malnutrition rats, but increased BDNF levels in post-malnourished rats at a dose of 22.5 mg/kg BW.

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