Bioequivalence of a novel oral metronidazole formulation

Arzneimittel-Forschung/Drug Research

Volumn 56, Issue 8, 2006, Pages 612-616

  Gatchev, Emil ^a   Bräter, Manfred ^b   De Mey, Christian ^c  

^a UNIVERSITY HOSPITAL ALEXANDROVSKA   (Bulgaria)

^b APOGEPHA Arzneimittel GmbH   (Germany)

^c ACPS Applied Clinical Pharmacology Services   (Germany)

Author keywords

Antibiotic drugs; CAS 443 48 1; CAS 4812 40 2; Metronidazole, bioequivalence, healthy volunteers, pharmacokinetics; Vagimid Dragees

Indexed keywords

METRONIDAZOLE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG METABOLISM; DRUG TOLERABILITY; HALF LIFE TIME; HUMAN; RANDOMIZED CONTROLLED TRIAL;

EID: 33748492098     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296760     Document Type: Article

References (3)

1. Cawello, W. (ed.), Parameters for compartment-free pharmacokinetics. Standardisation of study design, data analysis and reporting. Shaker Verlag, Aachen (1999)
2. Hauschke, D., Steinijans, V. W., Diletti, E., A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 30 (Suppl. 1), S37 (1992)
3. CPMP - Committee for proprietary medicinal products, Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401/91, July 2001