Efavirenz Comparative Bioavailability

Launched by CENTER FOR CLINICAL PHARMACOLOGY RESEARCH BDBEQ S.A. · Oct 11, 2012

Keywords

ClinConnect Summary

The primary objective of this study is to determine the average bioequivalence of 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), then they will undergo a 24 hour intensive pharmacokinetic evaluation after in...

Gender

MALE

Eligibility 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