Bioequivalence Evaluation of Acarbose Tablet in Healthy Chinese Volunteers with Pharmacodynamic Endpoints
HUANG Ming1, ZHANG Quan-ying1*, XU Feng-hua2, WANG Meng1, ZHOU Wen-jia1
1. Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China; 2. Department of Pharmacy, The Affiliated Suzhou Science & Technology Town Hospital of Nanjing Medical University, Suzhou 215153, China
Abstract：OBJECTIVE To evaluate the bioequivalence of acarbose tablet in healthy Chinese volunteers through the use of pharmacodynamics endpoint parameters of serum glucose. METHODS Following the Food and Drug Administration (FDA) guidance, a single oral dose of test and reference formulations was given to 32 healthy Chinese volunteers according to a randomized crossover design. Serum glucose concentrations after sucrose administration and co-administration of sucrose and acarbose on the following day were both determined. The reduction of serum glucose concentration were calculated following treatment with acarbose and sucrose together relative to the baseline serum glucose concentration observed . The parameters of Δcmax and AUEC0-4 h recommended by the FDA were used for bioequivalence evaluation. Four pharmacodynamics parameters of AUEC0-2 h,AUEC0-1.5 h, AUEC0-1.0 hand ΔGE were also tested in the evaluation. RESULTS The main pharmacodynamics parameters of serum glucose in test and reference formulations were as follows:Δcmax (1.169±0.719) and (0.878±0.571) mmol·L-1, AUEC0-2 h(46±25) and (50±21) mmol·min·L-1, AUEC0-1.5 h(62±42) and (70±29) mmol·min·L-1, AUEC0-1 h(59±52) and (73±32) mmol·min·L-1, ΔGE(1.829±0.952) and (1.656±0.764) mmol·L-1, respectively. The parameter AUEC0-4 h could not be evaluated due to the presence of negative values. CONCLUSION Acarbose tablet is bioinequivalent to the reference tablet.This might be related to acarbose dose, the 50 mg dose of acarbose tablet is inadequate. Pharmacodynamics parameters which is suitable to demonstrate acarbose bioequivalence might also need to be optimized.
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2019, Vol. 54 
