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
Details
Lead Sponsor:
Center for Clinical Pharmacology Research Bdbeq S.A.