Bioequivalence study for propiverine hydrochloride fine granule and tablet - Pharmacokinetics in healthy adult volunteers after single oral dose

Japanese Pharmacology and Therapeutics

Volumn 34, Issue 7, 2006, Pages 859-867

  Nishimura, Takako ^a   Iijima, Hajime ^a   Arisawa, Noriko ^a   Monuki, Yoko ^a   Hasunuma, Tomoko ^a   Yoshida, Ken Ichiro ^b   Komoto, Ikumi ^b   Kinoshita, Masahiro ^b   Ogata, Tetsuo ^b   Koide, Atsuo ^b   Chousa, Satoshi ^c   Horiuchi, Toshikazu ^c   Kumagai, Yuji ^d  

^a KITASATO INSTITUTE   (Japan)

^b TAIHO PHARMACEUTICAL CO LTD   (Japan)

^c SHIN NIPPON BIOMEDICAL LABORATORIES LTD   (Japan)

^d KITASATO UNIVERSITY HOSPITAL   (Japan)

Author keywords

Bioequivalence; Fine granule; Healthy volunteers; Plasma pharmacokinetics; Propiverine hydrochloride

Indexed keywords

PROPIVERINE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG FORMULATION; DRUG GRANULATION; HUMAN; HUMAN EXPERIMENT; JAPAN; NORMAL HUMAN; TABLET;

EID: 33749502966     PISSN: 03863603     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. Komoto I, Yoshida K, Matsushima E, Yamashita K, Aikawa T, Akashi S. Validation of a simple liquid chromatography-tandem mass spectrometric method for the determination of propiverine hydrochloride and its N-oxide metabolite in human plasma. J Chromatography B 2004; 799: 141-47.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicines (CVM). Guidance for Industry, Bioanalytical method validation. May 2001.
3. Cho SH, Lee HW, Im HT, Park WS, Baek M, Lee KT. Quantification of propiverine by liquid chromatography/electrospray tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy subjects. J Pharm Biomed Anal 2005; 39: 670-76.
4. Elfring GL, Metzler CM. The efficient use of NONLIN for unbalanced multiple dose data. J Pharmacokinet Biopharm 1981; 9 (4): 497-501.
5. Marunaka T, Umeno Y, Minami Y, Matsushima E, Maniwa M, Yoshida K, et al. Gas chromatographic-mass fragmentographic determination of propiverine and its metabolites in plasma and urine. J Chromatography 1987; 420: 43-52.