Bioequivalence of 3 batches of a fixed dose triple combination tablet

• Research type

  Research Study

• Full title

  A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioequivalence of Three Batches of the Fixed-dose Triple Combination Tablet of Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

• IRAS ID

  95477

• Contact name

  Ashley Brooks

• Sponsor organisation

  Bristol Myers-Squibb & Gilead Sciences Ltd.

• Eudract number

  2011-005266-38

• Research summary

  The aim of this study to evaluate the amount of drug that gets into the blood following administration of three different batches of the fixed-dose tablet containing three different drugs used in the treatment of HIV. 90 healthy volunteers will be enrolled with an approximate even distribution of healthy male and non-pregnant, non-lactating female subjects aged 18-45, inclusive. Following screening, eligible subjects will be enrolled and randomized on to one of six treatment sequences. Subjects will receive a single dose of drug on 3 occasions. On each occasion they will receive a different batch of the drug. Dosing will occur on Day 1, 35 and 69.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/IE/0001

• Date of REC Opinion

  30 Jan 2012

• REC opinion

  Further Information Favourable Opinion