Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers

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...

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Main Authors: Amorn Leelarasamee, Wallapa Tatong, Narat Kasattut, Tatta Sriboonruang, Duangchit Panomvana Na Ayudhya
Other Authors: Mahidol University
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Published: 2018
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Online Access:https://repository.li.mahidol.ac.th/handle/123456789/23759
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spelling th-mahidol.237592018-08-20T14:17:23Z Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers Amorn Leelarasamee Wallapa Tatong Narat Kasattut Tatta Sriboonruang Duangchit Panomvana Na Ayudhya Mahidol University Chulalongkorn University Medicine 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. 2018-08-20T07:17:23Z 2018-08-20T07:17:23Z 2006-05-01 Article Journal of the Medical Association of Thailand. Vol.89, No.5 (2006), 683-689 01252208 01252208 2-s2.0-33646772913 https://repository.li.mahidol.ac.th/handle/123456789/23759 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=33646772913&origin=inward
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Medicine
spellingShingle Medicine
Amorn Leelarasamee
Wallapa Tatong
Narat Kasattut
Tatta Sriboonruang
Duangchit Panomvana Na Ayudhya
Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
description 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.
author2 Mahidol University
author_facet Mahidol University
Amorn Leelarasamee
Wallapa Tatong
Narat Kasattut
Tatta Sriboonruang
Duangchit Panomvana Na Ayudhya
format Article
author Amorn Leelarasamee
Wallapa Tatong
Narat Kasattut
Tatta Sriboonruang
Duangchit Panomvana Na Ayudhya
author_sort Amorn Leelarasamee
title Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
title_short Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
title_full Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
title_fullStr Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
title_full_unstemmed Bioequivalence study of clindamycin phosphate injection (Clinott-P ) in Thai healthy volunteers
title_sort bioequivalence study of clindamycin phosphate injection (clinott-p ) in thai healthy volunteers
publishDate 2018
url https://repository.li.mahidol.ac.th/handle/123456789/23759
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