Assessing the bioequivalence of 4- and 8-mg benidipine tablets in healthy volunteers after a single oral dose

Journal of Clinical Pharmacy and Therapeutics

Volumn 30, Issue 1, 2005, Pages 85-90

  Kang, W K ^a   Yun, H Y ^b   Kwon, K I ^b  

^a Nondestructive Measurement Group   (South Korea)

^b Chungnam National University   (South Korea)

Author keywords

Benidipine; Bioequivalence; LC MS MS

Indexed keywords

BENIDIPINE; DIHYDROPYRIDINE DERIVATIVE; GENERIC DRUG;

ADULT; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG MARKETING; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; NORMAL HUMAN; SINGLE DRUG DOSE; TABLET; AREA UNDER THE CURVE; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; HALF LIFE TIME; MASS FRAGMENTOGRAPHY; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; DIHYDROPYRIDINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUGS, GENERIC; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HALF-LIFE; HUMANS; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 23844541781     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2004.00614.x     Document Type: Article

References (9)

1. Muto K, Kuroda T, Kawato H, Nishikawa H, Nakamizo N (1988) Synthesis of expected metabolites of benidipine hydrochloride. Arzneim Forsch/Drug Research, 38, 1666-1670.
2. Kobayashi H, Kobayashi S (1997) Relationship between plasma concentration and antihypertensive effect of the dihydropyridine calcium antagonist, benidipine, in rats. Journal of Pharmacy and Pharmacology, 49, 1200-1204.
3. Karasawa A, Kubo K, Shuto K, Oka T, Nakamizo N (1988) Pharmacological action of benidipine hydrochloride in several isolated smooth muscle and myocardium cells. Arzneim Forsch/Drug Research, 38, 1722-1729.
4. 3H-nitrendipine binding site. Arzneim Forsch/Drug Research, 38, 1681-1683.
5. Ishii A, Nishida K, Oka T, Nakamizo N (1988) Receptor binding properties of the new calcium antagonist benidipine hydrochloride. Arzneim Forsch/Drug Research, 38, 1677-1680.
6. Shimada S, Nakajima Y, Yamamoto K, Sawada Y, Iga T (1996) Comparative pharmacodynamics of eight calcium channel blocking agents in Japanese essential hypertensive patients. Biological and Pharmaceutical Bulletin, 19, 430-437.
7. Kobayashi H, Kobayashi S, Inoue A, Oka T, Nakamizo N (1988) Pharmacokinetic study of benidipine hydrochloride in rats and dogs. Arzneim Forsch/Drug Research, 38, 1750-1752.
8. Maier-Lenz H, Rode H, Lenau H et al. (1988) Benidipine hydrochloride: a new calcium-channel blocker of the dihydropyridine type. Arzneim Forsch/Drug Research, 38, 1757-1763.
9. Kang WK, Yun HY, Liu KH, Kwon KI, Shin JG (2004) Determination of benidipine in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B, 805, 311-314.