title: Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.
abstract: BACKGROUND
  RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis.
  
  
  METHODS
  This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore.
  
  
  OBJECTIVE
  To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination.
  
  
  METHODS
  This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference products under fasting conditions in a crossover fashion, with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration-time curve (AUC).
  
  
  RESULTS
  Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study.
  
  
  CONCLUSIONS
  The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.
authors: Pfizer Inc., Groton, Connecticut, USA.
authors: H F
authors: HF
authors: Wang
authors: Pfizer Inc., Groton, Connecticut, USA.
authors: R
authors: R
authors: Wang
authors: Pfizer Inc., Groton, Connecticut, USA.
authors: M
authors: M
authors: O'Gorman
authors: Pfizer Inc., New York City, New York, USA.
authors: P
authors: P
authors: Crownover
authors: Pfizer Inc., New York City, New York, USA.
authors: B
authors: B
authors: Damle
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007538:Isoniazid / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D012293:Rifampin / Q000493:pharmacokinetics*; D012846:Singapore; D013607:Tablets; D013810:Therapeutic Equivalency; D014376:Tuberculosis / Q000188:drug therapy; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D004338:Drug Combinations; D013607:Tablets; D007538:Isoniazid; D012293:Rifampin