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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Federal de Pernambuco
• Treatments: Lamivudine

Criteria

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;