title: Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.
abstract: OBJECTIVE
  To compare the pharmacokinetic properties of two newly developed generic ambroxol formulations with a branded innovator product in healthy Chinese male volunteers.
  
  
  METHODS
  This was a single-dose, randomized, open-label, three-period crossover study in healthy volunteers aged 18 - 45 years under fasting conditions. Subjects were assigned to receive 1 of 2 test formulations or a reference tablet of ambroxol 30 mg. Each study period was separated by a 1-week washout phase. Blood samples were collected at pre-specified times. A non-compartmental method was employed to determine pharmacokinetic properties (C(max), t(max), AUC(0-tlast), AUC(0-∞)) to test for bioequivalence. The predetermined regulatory range of 90% CI for bioequivalence was 80 - 125%.
  
  
  RESULTS
  24 subjects were enrolled in and completed the study. The geometric mean C(max) values for the test tablet, test capsule, and reference product were 82.73, 85.36, 84.56 ng/mL, and their geometric mean AUC(0-tlast) (AUC(0-∞)) were 660.87 (753.49), 678.98 (756.79), and 639.41 (712.14) ng x h/mL, respectively. For test tablet vs. reference, the 90% CIs of the least squares mean test/reference ratios of C(max), AUC(0-tlast), and AUC(0-∞) were 91.2% to 104.9%, 96.5% to 110.7%, and 98.8% to 113.4%, respectively. For test capsule, the corresponding values were 94.1% to 108.3%, 99.2% to 113.7%, and 99.2% to 113.9%, respectively. No adverse events occurred during the study.
  
  
  CONCLUSIONS
  The ambroxol 30 mg tablets and capsules were considered bioequivalent to the reference formulation in accordance with predetermined regulatory criteria.
authors.forename: Bo
authors.initials: B
authors.lastname: Jiang
authors.forename: Jin-Liang
authors.initials: JL
authors.lastname: Chen
authors.forename: Hong-Gang
authors.initials: HG
authors.lastname: Lou
authors.forename: Ling-Yan
authors.initials: LY
authors.lastname: Yu
authors.forename: Hua-Hao
authors.initials: HH
authors.lastname: Shen
authors.forename: Zou-Rong
authors.initials: ZR
authors.lastname: Ruan
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000551:Ambroxol / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D013810:Therapeutic Equivalency
chemical_list: D000551:Ambroxol