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

Universidade Federal de Pernambuco

Status and phase: Completed; Phase 1

Conditions: HIV INFECTIONS

Treatments: Drug: Epivir ® tablet 150-mg single dose (drug reference); Drug: Lamivudine 150-mg tablet single dose (drug test)

Study type: Interventional

Funder types: Other

Identifiers

NCT02604004

NUD_04_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Period 1

Active Comparator group

Description:

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

Treatment:

Drug: Lamivudine 150-mg tablet single dose (drug test)

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

Period 2

Experimental group

Description:

Lamivudine 150-mg tablet single dose (drug test)

Treatment:

Drug: Lamivudine 150-mg tablet single dose (drug test)

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