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Pharmacokinetics Study of Eplerenone Coated Tablets

2016-11-08 09:23:21 | BioPortfolio

Summary

The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition.

Description

This is a phase I study of eplerenone coated tablets of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in fasting administration. Sample size is 12 subjects, male and female, aged between 18 and 50 years old.

This is an open-label, unicenter study with three periods, three treatments and one sequence. Each subject will receive the following treatments at the following periods:

- Period 1: one coated tablet of eplerenone 25mg in fasting

- Period 2: one coated tablet of eplerenone 50mg in fasting

- Period 3: two coated tablets of eplerenone 50mg (100mg of eplerenone) in fasting Formulations will be administered in a single dose, orally in each period. Trial subjects will be admitted in three different periods of 24 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time for pharmacokinetics evaluation.

Primary objective is to evaluate the pharmacokinetics of formulations of eplerenone coated tablets of 25mg, 50mg and 100mg (two coated tablets of 50mg) in healthy subjects under fasting condition. As a secondary objective, it will be also evaluated the safe and tolerability of coated tablets of eplerenone.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Pharmacokinetics

Intervention

eplerenone

Location

CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
Campinas
São Paulo
Brazil
13087567

Status

Not yet recruiting

Source

Biolab Sanus Farmaceutica

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-08T09:23:21-0500

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Medical and Biotech [MESH] Definitions

Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.

Naturally occurring genetic variations associated with drug response (e.g., dosage, extent and rate of metabolic processes). While these variants are not markers for GENETIC PREDISPOSITION TO DISEASE they influence PHARMACOKINETICS and pharmacodynamics and often occur on genes encoding drug metabolism enzymes and transporters (e.g., ANGIOTENSIN CONVERTING ENZYME; CYTOCHROME P-450 CYP2D6).

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