Pharmacokinetic profile of BAY a 1040 GITS, a nifedipine once-a-day dosage form based on osmotic pump configuration

Japanese Journal of Clinical Pharmacology and Therapeutics

Volumn 33, Issue 5, 2002, Pages 195-204

  Tateishi, Tomonori ^b   Okumura, Kazuhito ^a   Orii, Yoshimitsu ^a   Koshimizu, Takashi ^a   Sekino, Hisakuni ^b   Kato, Hideaki ^b   Tanaka, Toshiaki ^a  

^a BAYER YAKUHIN LTD   (Japan)

^b NONE

Author keywords

GITS (gastrointestinal therapeutic system); Nifedipine; Pharmacokinetics; Slow release formulation

Indexed keywords

ADALAT CR; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; NIFEDIPINE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD PRESSURE MEASUREMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG HALF LIFE; DRUG SAFETY; ENTERIC COATED TABLET; HEADACHE; HUMAN; HUMAN EXPERIMENT; JAPAN; LIPID DIET; LIVER TOXICITY; MULTIPLE DRUG DOSE; NORMAL HUMAN; OPEN STUDY; OSMOTIC PUMP; PHARMACOKINETICS; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SLOW RELEASE FORMULATION; TABLET; TACHYCARDIA; VERTIGO;

EID: 0041319076     PISSN: 03881601     EISSN: None     Source Type: Journal    
DOI: 10.3999/jscpt.33.5_195     Document Type: Article

References (10)

1. Swanson, D. R., Barclay, B. L., Wong, P. S., et al.: Nifedipine gastrointestinal therapeutic system. Am. J. Med., 83 (suppl 6B): 3-9 (1987).
2. Grundy, J. S. and Foster, R. T.: The nifedipine gastrointestinal therapeutic system (GITS). Clin. Pharmacokinet., 80(1): 28-51 (1996).
3. A modified assay method of nifedipine and its metabolites in plasma with gas chromatography. Jpn. J. Clin. Pharmacol. Ther., 27(1): 141-142 (1996).
4. Jpn. J. Clin. Pharmacol. Ther., 32(1): 23-33 (2001).
5. Schäfer, H. G., Ahr, G., Beckermann, B., et al.: Harmonization of data evaluation in pharmacokinetics: a task force report. Bayer AG Report, No. R5747(P) (1992).
6. Navert, H.: Comparison of the single-dose and steady-state pharmacokinetics of 60 mg nifedipine controlled-release tablets in healthy adult males. Bayer AG Report, No. R5983(P) (1992).