Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers

Biopharmaceutics and Drug Disposition

Volumn 24, Issue 6, 2003, Pages 229-231

  Lohitnavy, Ornrat ^a   Lohitnavy, Manupat ^a   Sareekan, Kannika ^a   Polnok, Sanglar ^a   Taytiwat, Prawit ^a  

^a NARESUAN UNIVERSITY   (Thailand)

Author keywords

Bioequivalence; Clarithromycin; Pharmacokinetics

Indexed keywords

CLARITHROMYCIN; GENERIC DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; ELECTROCHEMISTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; TABLET FORMULATION; THAILAND; VALIDATION PROCESS; VOLUNTEER;

CLARITHROMYCIN; DRUGS, GENERIC; HUMANS; MALE; TABLETS; THAILAND; THERAPEUTIC EQUIVALENCY;

EID: 0141704301     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.341     Document Type: Article

References (9)

1. Langtry HD, Brogden RN. Clarithromycin. A review of its efficacy in the treatment of respiratory tract infections in immunocompetent patients. Drugs 1997; 53: 973-1004.
2. McCarty JM. Clarithromycin in the management of community-acquired pneumonia. Clin Ther 2000; 22: 281-294.
3. Alvarez-Elcoro S, Enzler MJ. The macrolides: erythromycin, clarithromycin, and azithromycin. Mayo Clin Proc 1999; 74: 613-634.
4. Carbon C, Poole MD. The role of newer macrolides in the treatment of community-acquired respiratory tract infection. A review of experimental and clinical data. J Chemother 1999; 11: 107-118.
5. Rodvold KA. Clinical pharmacokinetics of clarithromycin. Clin Pharmacokinet 1999; 37: 365-398.
6. Fraschini F, Scaglione F, Deinartini G. Clarithromycin clinical pharmacokinetics. Clin Pharmacokinet 1993; 25: 189-804.
7. Chu SY, Wilson DS, Deaton RL, Mackkenthun AV, Eason CN, Cavanaugh JH. Single- and multiple-dose pharmacokinetics of clarithromycin, a new macrolide antimicrobial. J Clin Pharmacol 1993; 33: 719-726.
8. Chu SY, Sennello LT, Sonders RC. Simultaneous determination of clarithromycin and (14R)-hydroxyclarithromycin in plasma and urine using high-performance liquid chromatography with electrochemical detection. J Chromatograph 1991; 571: 199-208.
9. FDA Guidelines, Bioequivalence Food and Drug Administration, Division of Bioequivalence, Office of Generic Drugs: Rockville, MD, 1 July 1992.