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Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg

NCT02518451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-08-07

No results posted yet for this study

Summary

This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.

Conditions

  • Healthy

Interventions

DRUG

Valsartan 160 mg film-coated caplets (test formulation)

In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.

DRUG

Valsartan 160 mg film-coated caplets (reference formulation)

In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Effi Setiawati, MSc · PT Equilab International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2014-03-31

Countries

  • Indonesia

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 NCT02518451 on ClinicalTrials.gov