Bioequivalence study of two minocycline capsule formulations in healthy volunteers

Arzneimittel-Forschung/Drug Research

Volumn 59, Issue 10, 2009, Pages 532-536

  Setiawati, Effi ^a   Purnomo, Asri ^a   Deniati, Siti Hawa ^a   Yunaidi, Danang Agung ^a   Handayani, Lucia Rat ^a   Harinato, Gunawan ^a   Santoso, Iwan Dwi ^a  

^a PT Equilab International   (Indonesia)

Author keywords

Acnez ; CAS 13614 98 7; Minocycline, bioavailability, bioequivalence, pharmacokinetics; Tetracycline antibiotics

Indexed keywords

ACNEZ; MINOCYCLINE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BIOEQUIVALENCE; BLOOD LEVEL; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG HALF LIFE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; SINGLE BLIND PROCEDURE; TREATMENT DURATION; ULTRAVIOLET RADIATION;

EID: 70449673389     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296438     Document Type: Article

References (8)

1. Physician's Desk Reference. 59th ed. Montvale, NJ: Thomson PDR; 2005. p.1957-1959
2. rd ed. London-Chicago: The Pharmaceutical Press; 2002. p. 224-225.
3. Guidelines for Bioequivalent Studies. Jakarta (Indonesia): National Agency for Drug and Food Control; Dec 2004.
4. Guidelines for Good Clinical Practice. Jakarta (Indonesia): National Agency for Drug and Food Control; 2001.
5. Mascher HJ. Determination of minocycline in human plasma by high-performance liquid chromatography with UV detection after liquid-liquid extraction [Abstract]. Chromatog Antibiot. 1998;812(1-2):339-342
6. Note for Guidance on Investigation of Bioavailability and Bioequivalence. London: The European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products. CPMP/EWP/QWP/1401/98; 26 July 2001.
7. Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Medicine (CVM); May 2001.
8. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991;29(1):1-8.