Evaluation of the effect of food and gastric pH on the single-dose pharmacokinetics of cabozantinib in healthy adult subjects

The effect of food on the absorption of pivampicillin hydrochloride and ampicillin potassium was compared in a single-dose, 3-way, cross-over study in fifteen healthy adult subjects. The antibiotics were given in their recommended doses in capsule form: 350 mg of pivampicillin and 500 mg of ampicillin. Ampicillin was administered in the fasting state while pivampicillin was administered both in the fasting state and during a standardized cooked breakfast. The presence of food caused a substantial decrease and delay in the absorption of pivampicillin. Pivampicillin administered during a meal, as recommended to minimize gastro-intestinal irritation, resulted in lower serum levels than those attained with ampicillin given without food. The average peak serum levels of pivampicillin taken during meals was 3.34 mcg/ml compared to 4.47 mcg/ml with ampicillin given in the fasting state. The total antibiotic coverage indicated by time-absorption curves was also considerably lower with pivampicillin than with ampicillin under conditions simulating those recommended during clinical use by the respective manufacturers.

Download Full-text

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

Case Medical Research ◽

10.31525/ct1-nct03969849 ◽

2019 ◽

Author(s):

Keyword(s):

Single Dose ◽

Healthy Adult ◽

Pharmacodynamic Effects ◽

Adult Participants

Download Full-text

Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers

Clinical Pharmacology in Drug Development ◽

10.1177/2160763x12447302 ◽

2012 ◽

Vol 1 (3) ◽

pp. 85-92 ◽

Cited By ~ 2

Author(s):

A. Berges ◽

J. Robertson ◽

J. Upward ◽

S. Meyers ◽

C. Chen

Keyword(s):

Single Dose ◽

Naproxen Sodium ◽

Healthy Adult ◽

Combination Tablet ◽

Adolescent Patients ◽

Adult Volunteers

Download Full-text

A Randomized, Double‐Blind, Single‐Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.606 ◽

2018 ◽

Vol 8 (3) ◽

pp. 361-370 ◽

Cited By ~ 1

Author(s):

Bonnie C. Shaddinger ◽

Georgios Vlasakakis ◽

Joseph Soffer ◽

Karl M. Thorpe ◽

Daniel Hatch ◽

...

Keyword(s):

Single Dose ◽

Crossover Study ◽

Healthy Adult ◽

Double Blind ◽

Adult Participants

Download Full-text

Pharmacokinetics and Safety of Intravenous Ceftolozane-Tazobactam in Healthy Adult Subjects following Single and Multiple Ascending Doses

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.06349-11 ◽

2012 ◽

Vol 56 (6) ◽

pp. 3086-3091 ◽

Cited By ~ 80

Author(s):

Benjamin Miller ◽

Ellie Hershberger ◽

David Benziger ◽

MyMy Trinh ◽

Ian Friedland

Keyword(s):

Single Dose ◽

Adverse Events ◽

Healthy Adult ◽

Volume Of Distribution ◽

Dose Administration ◽

Mean Values ◽

Multiple Doses ◽

Dosing Regimens ◽

Dose Levels ◽

Dose Limiting Toxicity

ABSTRACTThe pharmacokinetics and safety of ceftolozane, a novel cephalosporin, and tazobactam, a β-lactamase inhibitor, alone and in combination as a 2:1 ratio in single doses of up to 2,000 and 1,000 mg of ceftolozane and tazobactam, respectively, and multiple doses of up to 3,000 and 1,500 mg of ceftolozane and tazobactam, respectively, per day were evaluated in healthy adult subjects. In part 1, groups of six subjects each received single ascending doses of ceftolozane, tazobactam, and ceftolozane-tazobactam in a within-cohort crossover design. In part 2, groups of 5 or 10 subjects each received multiple doses of ceftolozane, tazobactam, or ceftolozane-tazobactam for 10 days. After a single dose of ceftolozane alone, the ranges of mean values for half-life (2.48 to 2.64 h), the total clearance (4.35 to 6.01 liters/h), and the volume of distribution at steady state (11.0 to 14.1 liters) were consistent across dose levels and similar to those observed when ceftolozane was coadministered with tazobactam. Mean values after multiple doses for ceftolozane alone and ceftolozane-tazobactam were similar to those seen following a single dose. The pharmacokinetics of the dosing regimens evaluated were dose proportional and linear. Ceftolozane-tazobactam was well tolerated and systemic adverse events were uncommon. Mild infusion-related adverse events were the most commonly observed following multiple-dose administration. Adverse events were not dose related, and no dose-limiting toxicity was identified.

Download Full-text