Effect of Multiple Oral Doses of the Potent CYP3A4 Inhibitor Clarithromycin on the Pharmacokinetics of a Single Oral Dose of Vonoprazan: A Phase I, Open-Label, Sequential Design Study

2016 ◽  
Vol 37 (3) ◽  
pp. 311-316 ◽  
Author(s):  
Helen Jenkins ◽  
Richard Jenkins ◽  
Alain Patat
Keyword(s):  
Oral Dose ◽  
Phase I ◽  
Single Oral Dose ◽  
Sequential Design ◽  
Cyp3a4 Inhibitor ◽  
Design Study ◽  
Open Label ◽  
Oral Doses

scholarly journals Effects of the Chinese Herbal Formulation (Liu Wei Di Huang Wan) on the Pharmacokinetics of Isoflavones in Postmenopausal Women

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Wirin Limopasmanee ◽  
Sunee Chansakaow ◽  
Noppamas Rojanasthien ◽  
Maleeya Manorot ◽  
Chaichan Sangdee ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Oral Dose ◽  
Single Oral Dose ◽  
Postmenopausal Women ◽  
Pharmacokinetic Parameters ◽  
Soy Milk ◽  
Open Label ◽  
Fixed Sequence ◽  
Time Curve ◽  
Oral Doses

A combination of soy isoflavones andLiu Wei Di Huang Wan(LWDHW) is potentially effective for postmenopausal women with intolerable vasomotor episodes who are not suitable candidates for hormonal therapy. The objective of this open-label, three-phase, crossover study was to determine the influence of both single and multiple oral doses of LWDHW on isoflavone pharmacokinetics in healthy postmenopausal women. Eleven subjects were assigned to receive the following regimens in a fixed sequence with washout periods of at least one week: Phase A, a single oral dose of soy milk; Phase B, a single oral dose of soy milk coadministered with LWDHW; and Phase C, multiple oral doses of LWDHW for 14 days followed by a single oral dose of soy milk. Blood samples were collected and mixed withβ-glucuronidase/sulfatase to hydrolyze isoflavone conjugates to their respective aglycones (i.e., daidzein and genistein) and were determined using high performance liquid chromatography. The pharmacokinetic parameters analyzed were maximal plasma concentrationCmax, time to reach peak concentrationTmax, area under the plasma concentration-time curve (AUC), and half-life (t1/2). The results found no statistically significant differences in pharmacokinetic parameters of daidzein and genistein among the three regimens.

scholarly journals Absolute Bioavailability of Esaxerenone and Food Effects on its Pharmacokinetics After a Single Oral Dose in Healthy Japanese Subjects: An Open-Label Crossover Study

2019 ◽  
Vol 36 (7) ◽  
pp. 1618-1627 ◽  
Author(s):  
Akifumi Kurata ◽  
Hidetoshi Furuie ◽  
Tomoko Ishizuka ◽  
Takafumi Nakatsu ◽  
Takako Shimizu ◽  
...  
Keyword(s):  
Oral Dose ◽  
Crossover Study ◽  
Single Oral Dose ◽  
Absolute Bioavailability ◽  
Food Effects ◽  
Open Label ◽  
Japanese Subjects

Kinetic effects of multiple oral doses of acetaminophen on a single oral dose of lamotrigine

1990 ◽  
Vol 48 (4) ◽  
pp. 346-355 ◽  
Author(s):  
Michelle Depot ◽  
J Robert Powell ◽  
John A Messenheimer ◽  
Gilles Cloutier ◽  
Michael J Dalton
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Kinetic Effects ◽  
Oral Doses

Mimosine, administered orally, and two related compounds of chemical defleecing agents for sheep

1978 ◽  
Vol 29 (5) ◽  
pp. 1065 ◽  
Author(s):  
PJ Reis ◽  
DA Tunks ◽  
AM Downes
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Intravenous Infusion ◽  
Fibre Diameter ◽  
Daily Ration ◽  
Before And After ◽  
Fibre Growth ◽  
High Concentrations ◽  
Oral Doses ◽  
Related Compounds

Oral doses of mimosine (ranging from 400 to 800 mg/kg body weight) were given to 71 sheep, either as two successive daily doses (10 sheep) or as a single dose (61 sheep). The effectiveness of these treatments for defleecing was assessed and in some sheep measurements were made of the concentration of mimosine in plasma after dosing, and of the rate of wool growth before and after dosing. In addition, the effectiveness as defleecing agents of two related compounds (an analogue of mimosine, 'isomimosine', and a metabolite, 3,4-dihydroxypyridine (DHP)) was assessed. Two successive daily doses of mimosine (300 mg/kg/day) allowed all sheep to be defleeced. With sheep consuming a daily ration of 600 g, a single oral dose of mimosine (400 mg/kg) was sufficient to allow defleecing of most sheep; when the daily ration was 1200 g, a dose of 600 mg/kg was required to allow defleecing of most sheep. The effectiveness of oral doses for defleecing could be explained by the absorption of mimosine over a period in excess of 24 hr. Concentrations of mimosine in plasma were usually above 100 µmoles/l 24 hr after an effective dose. Failure to achieve complete cessation of fibre growth occurred occasionally, irrespective of dose level, and two sheep died after dosing. Fasting prior to dosing appeared to obviate the effects of previous high nutrition, but increased the risk of toxic effects. Fasting resulted in exceptionally high concentrations of mimosine in plasma (200–300 µmoles/l) 1 and 2 days after dosing. Both fibre diameter and mass of wool grown were increased in the early regrowth after dosing with mimosine. 'Isomimosine' had a similar potency to mimosine for stopping fibre growth in sheep, whether given as an intravenous infusion or as a single oral dose. DHP, given as an intravenous infusion, was ineffective as a defleecing agent.

scholarly journals 1393. A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Subjects Under Fasting Conditions of Orally Administered Sulopenem Etzadroxil Alone or with Probenecid to Determine the Pharmacokinetics of Sulopenem

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S428-S429
Author(s):  
Michael Dunne ◽  
Steven Aronin ◽  
Elise Dunzo ◽  
Sailaja Puttagunta
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Phase 1 ◽  
Treatment Options ◽  
Parent Compound ◽  
Additional Treatment ◽  
Open Label ◽  
Males And Females ◽  
The Mean ◽  
Mean Time

Abstract Background Antimicrobial resistance to available oral antibiotics is becoming progressively more common, precipitating the need for additional treatment options as step-down from initial intravenous (IV) therapy as well as for treatment of infections in the community. Sulopenem (CP-70,429) is a thiopenem antibiotic active against quinolone non-susceptible and ESBL-producing Enterobacteriaceae. As the key pharmacokinetic-pharmacodynamic variable correlating with efficacy for penem antibiotics is time above minimum inhibitory concentration (T > MIC), we examined the utility of probenecid, an OAT-1 inhibitor of β-lactam excretion, on the pharmacokinetic (PK) parameters for the oral prodrug of sulopenem, sulopenem etzadroxil Methods Twelve healthy males and females received a single oral dose of 500 mg sulopenem etzadroxil as powder in bottle either alone or co-administered with a single oral dose of probenecid 500 mg in a crossover design with a washout period of 6 days. All doses were administered under fasting conditions. Blood samples for plasma PK analysis were collected and PK parameters for sulopenem, the parent compound of sulopenem etzadroxil, were determined. Results Treatment Conclusion Probenecid increases the AUC of sulopenem by 28% in the fasted state and extends the mean time over MIC. Disclosures M. Dunne, Iterum Therapeutics: Employee and Shareholder, Salary. S. Aronin, Iterum Therapeutics: Employee and Shareholder, Salary. E. Dunzo, Parexel: Consultant, Consulting fee. S. Puttagunta, Iterum Therapeutics: Employee and Shareholder, Salary.

Effects of repeated oral doses of ketoconazole on a sequential ascending single oral dose of fedratinib in healthy subjects

2020 ◽  
Vol 85 (5) ◽  
pp. 899-906 ◽  
Author(s):  
Ken Ogasawara ◽  
Christine Xu ◽  
Vanaja Kanamaluru ◽  
Maria Palmisano ◽  
Gopal Krishna
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Healthy Subjects ◽  
Oral Doses
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