Pharmacokinetics and bioequivalence study of clindamycin hydrochloride formulations after single-dose administration in healthy Chinese male volunteers

Arzneimittel-Forschung/Drug Research

Volumn 58, Issue 7, 2008, Pages 358-362

  Li, Jing ^a   Wang, Na ^a   Zhang, Zun Jian ^a   Tian, Yuan ^a   Tang, Weiguo ^b   Chen, Yun ^c  

^a CHINA PHARMACEUTICAL UNIVERSITY   (China)

^b Jinling Pharmaceutical Co Ltd   (China)

^c INSTITUTE OF DERMATOLOGY   (China)

Author keywords

Antibiotics; CAS 18323 44 9; CAS 21462 39 5; Clindamycin; Clindamycin hydrochloride, bioequivalence, pharmacokinetics

Indexed keywords

CLINDAMYCIN;

ADULT; ARTICLE; BIOEQUIVALENCE; CHINESE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; ELECTROSPRAY MASS SPECTROMETRY; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VOLUNTEER;

EID: 49449089109     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296520     Document Type: Article

References (12)

1. La Follette G, Gambertoglio J, White JA, Knuth DW, Lin ET. Determination of clindamycin in plasma or serum by high-performance liquid chromatography with ultraviolet detection. J Chromatogr. 1988;431:379-388.
2. [2! Yu LL, Chao CK, Liao WJ, Twu TY, Liu CM, Yang TH, et al. Determination of clindamycin in human plasma by liquid chromatography- electrospray tandem mass spectrometry: application to the bioequivalence study of clindamycin. J Chromatogr B Biomed Sci Appl. 1999;724:284-294.
3. Batzias GC, Delis GA, Koutsoviti-Papadopoulou M. A new HPLC/UV method for the determination of clindamycin in dog blood serum. J Pharm Biomed Anal. 2004;35:545-554.
4. Phillips I. Clinical used and control of rifampicin and clindamycin. J Clin Pathol. 1971;24:410-418.
5. DeHaan RM, Metzler CM, Schellenberg D, VandenBosch WD, Masson EL. Pharmacokinetic studies of clindamycin hydrochloride in humans. Int J Clin Pharmacol. 1972;6: 105-119.
6. Gatti G, Malena M, Casazza R, Borin M, Bassetti M, Cruciani M. Penetration of clindamycin and its metabolite N-demethylclindamycin into cerebrospinal fluid following intravenous infusion of clindamycin phosphate in patients with AIDS. Antimicrob Agents Chemother. 1998;42:3014-3017.
7. Si H Yang, Myung G Lee. Dose-independent pharmacokinetics of clindamycin after intravenous and oral administration to rats: Contribution of gastric first-pass effect to low bioavailability. Int J Pharm. 2007;332:17-23.
8. Gatti G, Flaherty J, Bubp J, White J, Borin M, Gambertoglio J. Comparativestudy of bioavailabilities and pharmacokinetics of clindamycin in healthy volunteersand patients with AIDS. Antimicrob Agents Chemother. 1993:37:1137-1143.
9. Mazur D, Schug BS, Evers G, et al. Bioavailability and selected pharmacokineticparameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation. Int J Clin Pharmacol Ther. 1999;37(8):386-392
10. Schulz HU, Steinijans VW. Striving for standards in bioequivalence assessments review. Int J Clin Pharmacol Ther Toxicol. 1991;29:293-298
11. Gardner S. Bioavailability and bioequivalence requirements. Procedures for establishing a bioequivalence requirement. Fed Reg. 1977;42:1624-1653
12. Note for Guidance on the Investigation of Bioavailability and Bioequivalence Committee for Proprietary Medicinal Products. CPMP/EWP/QWP/1401/ 98. London; 26 July 2001.