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Bioequivalence Study of 4 mg Glimepiride Tablet

NCT01677247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-08-31

No results posted yet for this study

Summary

This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).

Conditions

  • Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Interventions

DRUG

Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica

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

DRUG

Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis

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

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Danang A. Yunaidi, MD · 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
2011-02-28
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT01677247 on ClinicalTrials.gov