NCT02957435

Pharmacokinetics Study of Eplerenone Coated Tablets

Phase I, Open-label, Three Periods Study in Health Male and Female Subjects, Under Fasting Condition for Evaluation of Pharmacokinetics Profile of Single Dose of Eplerenone in Coated Tablets Formulation on Concentrations of 25mg, 50mg and 100mg, Produced by Biolab Sanus Farmacêutica Ltda

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pharmacokinetics
• Healthy Subjects
• Fasting

Interventions

Type	Name	Description
DRUG	eplerenone	(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3)

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-11-07
• Last updated: 2018-06-06

Locations

1 site across 1 country: Brazil