NDLI: Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.

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Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.

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Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Jiang, Bo Chen, Jin-Liang Lou, Hong-Gang Yu, Ling-Yan Shen, Hua-Hao Ruan, Zou-Rong
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.
File Format	HTM / HTML
ISSN	09461965
Issue Number	10
Volume Number	52
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2014-10-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Ambroxol Pharmacokinetics Administration, Oral Adolescent Adult Area Under Curve Chemistry, Pharmaceutical Cross-over Studies Healthy Volunteers Humans Male Therapeutic Equivalency Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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