Journal of Bioequivalence & Bioavailability

Clinical Research Center, China State Institute of Pharmaceutical Industry, Shanghai 200437, China

Publications

• Research Article   
  Bioequivalence Studies of Two Calcitriol Capsules Formulation in Healthy Chinese Subjects under Fasting and Fed Conditions: The Randomized, Open-Label, Single-Dose, Crossover Studies
  Author(s): Na Ni, Yangsheng Chen, Shengjun Qu, Junlong Wang, Lei Wang and Bin Zhou*
  
  Background: To evaluate the bioequivalence between test and reference formulations of calcitriol capsules under fasting and fed conditions and to assess their Pharmacokinetic (PK) and safety profiles. Methods: A randomized, open-label, single-dose, crossover studies were conducted in healthy Chinese subjects. Test calcitriol capsules (T) or reference calcitriol capsules (R, 4.0 μg, 8 dosage units with the strengths of 0.5 μg per capsules) were randomly given to subjects under fasting (3-way 3-period crossover), with an administration sequence of T-R-R, R-T-R or R-R-T and fed (2-way 2-period crossover), with an administration sequence of T-R or R-T conditions, while each single administration was followed by a 14-day washout period. The plasma concentration and corresponding PK parameters of calcitriol were determined. T.. View more»
  

  DOI: 10.35248/0975-0851.22.14.483

  Abstract HTML PDF