Efavirenz Comparative Bioavailability

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to determine the average bioequivalence of a generic efavirenz 600 mg tablet (test formulation)compared with Stocrin(R) 600 mg tablets (Reference formulation).The study is designed as an open label, randomized, crossover, 2-treatments, 2-period, 2-sequence, single dose pharmacokinetic study conducted in healthy volunteers. Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or Stocrin(R) 600 tablets (Reference formulation)on study day 1 (period 1). Subjects will undergo a 24 hour intensive pharmacokinetic evaluation after ingesting a single dose of either the Test or Reference formulation. Subjects will provide additional pharmacokinetic samples 36, 48, 72, 120 and 192 hours postdose, respectively. Subjects will complete a wash out period from day 8 to day 28 during wich no study drug will be ingested. On day 29 subjects will ingest either the Test or the Reference formulation (opposite to the formulation received on period 1). All subjects undergo another 24 hour intensive pharmacokinetic evaluation and pharmacokinetics samples on days 36, 48, 72, 120, 192 pos dose, respectively. Adverse events and and concomitant medication will be documented throughout the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A.
• Collaborator: University of the Republic, Uruguay
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

• Male,

• Caucasians

• Age >=18 and <=50,

• BMI>18 and BMI<30 kg/m2

• HIV-1 negative, B Hepatitis negative, C Hepatitis negative.

• Able to give consent,

• Non/light-smoking,

• Lab screening and EKG within the limits stipulated in the protocol.

• Healthy as determine by medical examination.

Exclusion Criteria:

• Subjects with any current or past history of psychiatric disorder.

• Subjects receiving any prescription or over-the-counter product.

• Subjects using any form of recreational drug.

• Subjects who has eaten grapefruit or drunk grapefruit juice during the last 15 days before administration of study drug.

• Subjects who had had xanthine containing beverages (mate, coffee, tea, chocolate, etc.) during 48 ours previous to study drug administration.

• Subjects with history of hepatic disease, renal disease, GI diseases, chronic infectious disease, heart disease, lung disease, neurologic disease, endocrine disease, etc.

• Subjects suffering any acute disease at screening or check-in.

• Alanine S. Transaminase(AST)/Alanine L. Transaminase(ALT) > 3 times upper limit of normal (ULN).

• Bilirubin > 2.5 times ULN.

• Amylase > 2 times ULN.

• Absolute Neutrophil Count <1000/mL.

• Hgb < 9.0 g/dl.

• Platelets > 50.000 cell/mm3,

• Serum Creatinine > 2.5 mg/dl