NCT02604004

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

Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universidade Federal de Pernambuco · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

It is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of Phase I. So the study was initiated and completed with the participation of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in each stage.

Conditions

• HIV INFECTIONS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-11-13
• Last updated: 2015-11-13