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Pharmacokinetics Study of Eplerenone Coated Tablets

NCT02957435 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-06-06

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Healthy Subjects
  • Fasting

Interventions

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)

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • Pedro S Junior, MD · CAEP - Centro Avançado de Estudos e Pesquisa Ltda.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957435 on ClinicalTrials.gov