Related Experiment Video
Updated: Jan 9, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Bioequivalence and safety evaluation of betahistine hydrochloride tablets: a randomized, open - label, crossover
Zhixiang Pan1, Guan Liu1, Fang Yao1
1Phase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Background:
Betahistine hydrochloride is critical for Ménière's syndrome treatment. Validating bioequivalence of generic and reference formulations under fasting/postprandial conditions is key for clinical substitution.
Research Design And Methods:
Single-center, randomized, open-label, two-period crossover study; 26 healthy subjects per arm. Test (Tianfang) and reference (Mylan) 8 mg tablets were compared. Plasma 2-pyridineacetic acid quantified via UPLC-MS/MS. Safety monitored via adverse events, vital signs, and labs.
Results:
90% CIs for Cmax/AUC0-t/AUC0-∞ (test/reference) were 80%-125%. Adverse events were mild (fasting: test 23.1%, reference 19.2%; postprandial: test 26.9%, reference 7.7%); no severe reactions.
Conclusions:
Test formulation is bioequivalent and well-tolerated to reference, supporting interchangeability. Limitations: small single-center sample, healthy subjects.
More Related Videos
07:02A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
08:18Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
Published on: July 27, 2022
Related Concept Videos
Bioequivalence of Drugs: Drugs with Multiple Indications
Bioequivalence studies: Biowaivers
Bioequivalence: Overview
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Bioequivalence Data: Statistical Interpretation
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs