Assessment of the bioequivalence of different formulations containing azithromycin (tablets and suspension)

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 9 A, 2004, Pages 578-582

  Koytchev, Rossen ^a,e   Ozalp, Yildiz ^b   Erenmemisoglu, Aydin ^c   Van Der Meer, Mike John ^d   Alpan, Recep Serdar ^b  

^a Coop Clin Drug R and D ^*  (Germany)

^b EIS Eczacibasi Ilac Sanayi ve T   (Turkey)

^c ERCIYES UNIVERSITY   (Turkey)

^d Trident Bioanalytics Ltd   (Ireland)

^e Coop Clin Drug R and D AG ^*  (Germany)

Author keywords

Azithromycin, bioequivalence, clinical pharmacokinetics; Azro ; CAS 11772 70 0

Indexed keywords

AZITHROMYCIN; AZRO;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG TOLERANCE; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSPENSION; TABLET FORMULATION;

EID: 4644221896     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297052     Document Type: Article

References (10)

1. Langtry, H, D., Baldour, J. A., Azithromycin. A review of its use in paediatric infectious diseases. Drugs 56, 273 (1998)
2. Kirst, H. A., Sides, G. D., New directions for macrolide antibiotics: pharmacokinetics and clinical efficacy. Antimicrob. Agents Chenother. 33, 1419 (1989)
3. Peters, D. H., Friedel, H. A., McTavish, D., Azithromycin. A review of its antimicrobial activity, pharmacokinetic properties and clinical efficacy. Drugs 44, 750 (1992)
4. Hauschke, D., Steinijans, V., Diletti, E., A distribution free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 28, 72 (1990)
5. Foulds, G., Shephard, R. M., Johnson, R. B., The pharmacokinetics of azithromycin in human serum and tissues. J. Antimicrob. Chemother. 25 (Suppl. A), 73 (1990)
6. Johnson, R. B., The role of azalide antibiotics in the treatment of chlamydia. Am. J. Obstetr. Gynecol. 164, 1794 (1991)
7. Lode, H., The pharmacokinetics of azithromycin and their clinical significance. Eur. J. Clin. Microbiol. Infect. Dis. 10, 807 (1991)
8. Lalak, N. J., Morris, D. L., Azithromycin clinical pharmacokinetics. Clin. Pharmacokinet. 25, 370 (1993)
9. CPMP Note for Guidance: Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 (1998)
10. Cooper, M. A., Nye, K., Andrews, J. M. et al., The pharmacokinetics and inflammatory fluid penetration of orally administered azithromycin. J. Antimicrob. Chemother. 26, 533 (1990)