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

Phase 1

Completed

• Conditions: HIV INFECTIONS
• Interventions: Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)

• Registration Number: NCT02604004
• Lead Sponsor: Universidade Federal de Pernambuco

Brief 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Study First Posted: 2015-11-13
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Considered healthy after undergoing a clinical evaluation;
• Agree freely and sign the Recruitment and Informed Consent Term, after all the content of the protocol was clear before any procedure;
• Present the body mass index greater than 19 and less than 30.

Exclusion Criteria

• Results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant;
• Allergic to lamivudine or any other drug;
• Positive outcome of the pre-admission pregnancy test;
• Regular medication within four (4) weeks prior to the start of the study or use of any medication to present interaction with lamivudine one week before the start of the study;
• Use abusive alcoholic beverage;
• Use of illicit drugs and tobacco;
• History of liver disease, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric; hypo- or hypertension of any cause that required pharmacological treatment; myocardial infarction, angina and / or heart failure;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1	Lamivudine 150-mg tablet single dose (drug test)	Epivir ® tablet 150-mg single dose (drug reference)
Period 2	Epivir ® tablet 150-mg single dose (drug reference)	Lamivudine 150-mg tablet single dose (drug test)
Period 2	Lamivudine 150-mg tablet single dose (drug test)	Lamivudine 150-mg tablet single dose (drug test)
Period 1	Epivir ® tablet 150-mg single dose (drug reference)	Epivir ® tablet 150-mg single dose (drug reference)

Primary Outcome Measures

Name	Time	Method
AUClast	Up to 36 hours	Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.

Secondary Outcome Measures

Name	Time	Method
T1/2	Up to 72 hours	Terminal half-time of lamivudine in plasma.
Cmax	Up to 36 hours	Maximum concentration (Cmax) of lamivudine in plasma.
AUCinf	Up to 36 hours	Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.
Tmax	Up to 36 hours	Time for Maximum concentration (Tmax) of lamivudine in plasma.