Publication: Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
Issued Date
2006-05-01
Resource Type
ISSN
01252208
01252208
01252208
Other identifier(s)
2-s2.0-33646772913
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.89, No.5 (2006), 683-689
Suggested Citation
Amorn Leelarasamee, Wallapa Tatong, Narat Kasattut, Tatta Sriboonruang, Duangchit Panomvana Na Ayudhya Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers. Journal of the Medical Association of Thailand. Vol.89, No.5 (2006), 683-689. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/23759
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
Other Contributor(s)
Abstract
Background and Objective: Generic clindamycin given intramuscularly, should have identical active ingredient(s), strength, and demonstrable bioequivalence to those of original product. The aim of this investigation was to compare the bioavailability of a single, intramuscular injection, of 2 ml. of 300 mg. of a generic clindamycin (Clinott-P ) and the original preparation (Dalacin C ). Material and Method: A randomized, double-blinded, crossover study was conducted. Twenty-four healthy males were recruited at Siriraj Hospital and randomized to receive a single intramuscular injection of either Clinott-P or Dalacin C . Treatment was followed by a two-week washout period. Blood samples were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours after the injection. Plasma samples were analysed for clindamycin by a validated HPLC method at the Faculty of Pharmaceutical Sciences, Chulalongkorn University. Results: Twenty-four volunteers enrolled in and completed the study. They exhibited an average height of 167.92 cm (SD = 5.82), weight of 60.10 kg (SD = 7.36), body mass index of 21.27 (SD = 1.73) and normal blood chemistries. The C max of Clinott-P was 3.94225 μg/ml at T max 1.75 hours and of Dalacin C , 3.6847 μg/ml at T max 2.09 hours. The AUC 0-24 of Clinott-P was 16.32 ± 6.13 μg.hr/ml and Dalacin C was 17.24 ± 7.46 μg.hr/ml. Ninety percent confidence intervals of the mean ratios (test/reference) of log transformed of C max (93.07-123.43%), AUC (0-24) (82.58-112.31%) and AUC (0-inf) (81.54-110.06%) were all within the standard range (80-125 %) for bioequivalence study. Tenderness after injection around the deltoid area was assessed blindly and was found to be slight (visual basic score < 5) and presented for one or two days after the injection. Conclusion: The two brands of clindamycin exhibit comparable pharmacokinetic parameters and volunteers exhibited slight and tolerable tenderness at the injection site.