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Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers

NCT02604004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-11-13

No results posted yet for this study

Summary

The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.

Conditions

  • HIV INFECTIONS

Interventions

DRUG

Epivir ® tablet 150-mg single dose (drug reference)

Bioequivalence lamivudine 150 mg tablets fasting condition

DRUG

Lamivudine 150-mg tablet single dose (drug test)

Bioequivalence lamivudine 150 mg tablets fasting condition

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

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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 NCT02604004 on ClinicalTrials.gov