Journal of Bioequivalence & Bioavailability

Kah Hay Yuen

Publications

• Research Article
  Bioequivalence Study of Two Loperamide Hydrochloride 2 mg Formulations: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study in Healthy Volunteers under Fasting Conditions
  Author(s): Wen Yao Mak, Yi Lin Lee, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay YuenWen Yao Mak, Yi Lin Lee, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay Yuen
  
  The objective of this study was to compare the rate and extent of drug absorption of the test product (Colodium 2 mg Capsule, Hovid Bhd.) against the reference product (Imodium® 2 mg Capsule, Janssen Cilag S.A.) in twentythree healthy male volunteers under fasting condition in order to evaluate bioequivalence. A single dose of 8 mg (4 capsules of 2 mg each) of test and reference products were given to volunteers during two periods of the study respectively. There was a 7 day washout period between the two study periods. Blood samples were taken at pre-dose and at 13 time points up till 48 h post dosing. Plasma levels of loperamide were determined by liquid chromatography-tandem mass spectrometry. The plasma concentration-time data was used to estimate the pharmacokinetic parameters, namely, Cmax, Tmax, AUC0-t and AUC0-∞. Analysis of variance (ANO.. View More»
  DOI: 10.4172/jbb.1000285

  Abstract PDF