title: Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin.
abstract: OBJECTIVE
  The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers.
  
  
  METHODS
  A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC(0-∞), AUC(0-t), C(max), K(e), tmax and t(1/2) were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data.
  
  
  RESULTS
  24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19 - 45 years); height, 175.8 (10.6) cm (range 159.0 - 192.0 cm); weight, 75.6 (11.0) kg (range 58 - 101 kg); and body mass index, 24.4 (1.8) kg/m² (range 21.3 - 28 kg/m²) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms.
  
  
  CONCLUSIONS
  The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra.
authors: Analytical Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia. zeyad.talla@kaust.edu.sa
authors: Z A
authors: ZA
authors: Al-Talla
authors: S H
authors: SH
authors: Akrawi
authors: A-H M
authors: AH
authors: Emwas
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D001835:Body Weight / Q000502:physiology; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D002981:Clindamycin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D007202:Indicators and Reagents; D009682:Magnetic Resonance Spectroscopy; D008297:Male; D011786:Quality Control; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D007202:Indicators and Reagents; D002981:Clindamycin