Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers

2020 ◽  
Author(s):  
Keyword(s):  
Food Effect ◽  
Effect Study ◽  
Open Label ◽  
Healthy Human ◽  
Human Volunteers

Bioavailability and pharmacokinetic study of Metformin 500 mg tablet (SR formulations) in healthy human volunteers

2017 ◽  
Vol 3 (3) ◽  
pp. 354-358
Author(s):  
Ashish Kumar ◽  
Pradeep Singh ◽  
Garima Mishra
Keyword(s):  
Bioequivalence Study ◽  
Metformin Hydrochloride ◽  
Reference Standard ◽  
Reference Formulation ◽  
Open Label ◽  
Healthy Human ◽  
Fasting Condition ◽  
Test Formulation ◽  
Acceptable Range ◽  
Human Volunteers

Bioavailability and Bioequivalence studies have become an important part of the clinical research in India. This study was performed to find out the safety and efficacy of two Metformin 500 mg tablet (SR formulations). This study was an open label, balanced, randomized, two treatment, two periods, two sequences, single dose, cross over bioequivalence study under fasting condition. Metformin Hydrochloride (SR) 500 mg tablet was the Test formulation and Dibeta SR tablet [containing Metformin Hydrochloride (SR) 500 mg] was the Reference standard. Volunteers were randomly given a single oral dose of the test and the reference formulation under fasting condition, with a washout period of 07 days. Drug concentration in the plasma samples were quantified by using a validated method on LC/MS/MS. Win Nonlin Version 5.2 software was used for statistical calculations. Cmax, AUC0-t and AUC0-∞ values of the test formulation and reference standard were 89.13%, 87.46%, 88.29%, and 112.44%, 123.85% and 123.87%, respectively. Cmax, AUC0-t and AUC0- ∞ values of the test formulation and reference standard fall within the acceptable range of 80–125%. So, the present study concludes that the test formulation is bioequivalent to the reference standard.

scholarly journals Activation of the kallikrein-kinin system after endotoxin administration to normal human volunteers

Blood ◽  
1993 ◽  
Vol 81 (12) ◽  
pp. 3313-3317 ◽  
Author(s):  
RA DeLa Cadena ◽  
AF Suffredini ◽  
JD Page ◽  
RA Pixley ◽  
N Kaufman ◽  
...  
Keyword(s):  
Plasma Levels ◽  
Systemic Blood Pressure ◽  
Factor Xii ◽  
Open Label ◽  
Healthy Human ◽  
Kinin System ◽  
Healthy Humans ◽  
Clinical Center ◽  
Human Volunteers ◽  
Kallikrein Kinin System

The objective of this study was to determine the role of the kallikrein- kinin system in healthy humans after intravenous administration of either Escherichia coli endotoxin or saline. We studied a total of 18 healthy nonsmoking volunteers, 23 to 38 years old, in an open-label study at the Critical Care Medicine Department, Clinical Center, National Institutes of Health (Bethesda, MD) in which some of the patients served as their own controls. After baseline data collection, the subjects received intravenously either E coli endotoxin (n = 15, 4 ng/kg of body weight) or saline (n = 8, controls). Signs, symptoms, systemic blood pressure, factor XII, plasma prekallikrein (PK), factor XI (FXI), antithrombin III (AT-III), high molecular weight kininogen (HK), and alpha 2-macroglobulin-kallikrein complexes were measured at baseline and 1, 2, 3, 5, and 24 hours after injection of either saline or endotoxin. After infusion of endotoxin, we found the functional plasma levels of FXI decreased at 2 hours (P < .05) and at 5 hours (P < .05). Functional PK was significantly depressed by 2 hours (P < .05), at 5 hours (P < .05), and at 24 hours (P < .01), whereas the PK antigen was only low at 5 hours (P < .05). These changes were accompanied by a significant increase in circulating alpha 2-macroglobulin-kallikrein complexes at 3 hours (P < .05) and 5 hours (P < .01). No significant changes occurred in the plasma levels of factor XII or HK. We concluded that clinical response to intravenous endotoxin in healthy human volunteers is associated with activation of the kallikrein-kinin systems. Further investigation is needed with specific inhibitors of the kallikrein-kinin system to define its primary or secondary role in the endotoxin-mediated reactions.

scholarly journals Food-effect study on uracil and dihydrouracil plasma levels as marker for dihydropyrimidine dehydrogenase activity in human volunteers

2018 ◽  
Vol 84 (12) ◽  
pp. 2761-2769 ◽  
Author(s):  
Linda M. Henricks ◽  
Bart A. W. Jacobs ◽  
Didier Meulendijks ◽  
Dick Pluim ◽  
Daan van den Broek ◽  
...  
Keyword(s):  
Dehydrogenase Activity ◽  
Plasma Levels ◽  
Food Effect ◽  
Dihydropyrimidine Dehydrogenase ◽  
Effect Study ◽  
Human Volunteers

scholarly journals A phase 1, open-label, single-arm study evaluating the ocular safety of OTX-101 and systemic absorption of cyclosporine in healthy human volunteers

2019 ◽  
Vol Volume 13 ◽  
pp. 591-596 ◽  
Author(s):  
Paul M Karpecki ◽  
Sidney L Weiss ◽  
William G Kramer ◽  
Patrick O'Connor ◽  
David Evans ◽  
...  
Keyword(s):  
Phase 1 ◽  
Systemic Absorption ◽  
Open Label ◽  
Healthy Human ◽  
Human Volunteers ◽  
Ocular Safety

A Phase I, Dose-escalation Trial Evaluating the Safety and Efficacy of Emulsified Isoflurane in Healthy Human Volunteers

2014 ◽  
Vol 120 (3) ◽  
pp. 614-625 ◽  
Author(s):  
Han Huang ◽  
Rui Li ◽  
Jin Liu ◽  
Wensheng Zhang ◽  
Tianzhi Liao ◽  
...  
Keyword(s):  
Phase I ◽  
Dose Escalation ◽  
Dose Range ◽  
Vital Signs ◽  
Complete Recovery ◽  
Injection Pain ◽  
Open Label ◽  
Healthy Human ◽  
Single Bolus ◽  
Human Volunteers

Abstract Background This first-in-human volunteer phase I clinical trial aimed to evaluate the safety, tolerability, and anesthesia efficacy of emulsified isoflurane (EI), an intravenously injectable formulation of isoflurane. Methods Seventy-eight healthy volunteers were recruited in this open-label, single-bolus, dose-escalation, phase I trial and were allocated into 16 cohorts. Each volunteer received a single bolus injection of EI. The dose started with 0.3 mg/kg (for isoflurane) and was planned to end with 64.6 mg/kg. Postdose vital signs, physical examination, laboratory tests, chest radiograph, 12-lead electrocardiogram, and development of any adverse event were closely monitored as safety measurements. Effectiveness in producing sedation/anesthesia was assessed by Modified Observer’s Assessment of Alertness/Sedation and Bispectral Index. Results The dose escalation ended as planned. The most common adverse events associated with EI were injection pain (77 of 78, 98.7%) and transient tachycardia (22 of 78, 25.6%). Only at high doses (≥38.3 mg/kg) did EI cause transient hypotension (5 of 78, 6.4%) or apnea (11 of 78, 14.1%), but all the affected volunteers recovered uneventfully. Fast onset of unconsciousness (typically 40 s after injection) was developed in all volunteers receiving doses of 22.6 mg/kg or greater. Waking-up time and depression in Modified Observer’s Assessment of Alertness/Sedation correlated well with EI dose. None of the postdose tests revealed any abnormal result. Conclusions EI is safe for intravenous injection in human volunteers in the dose range of 0.3 to 64.6 mg/kg. At doses of 22.6 mg/kg or higher, EI produced rapid onset of unconsciousness in all volunteers followed by fast, predictable, and complete recovery.

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