Pharmacokinetics and comparative bioavailability of two diltiazem tablet formulations healthy volunteers
DARU-Journal of Faculty of Pharmacy Tehran University of Medical Sciences. 2003; 11 (1): 14-8
in English
| IMEMR
| ID: emr-61784
ABSTRACT
The pharmacokinetic parameters and bioavailability of diltiazem following a single oral administration of a generic diltiazem 60 mg tablet [Sobhan Pharmaceuticals, Iran] were compared to those of a reference product [Entrydil, Orion Pharmaceuticals, Finland]. Twelve healthy male volunteers received a single oral dose of either formulation following overnight fasting in a double blind, randomized, crossover study. Blood samples were collected at selected times during 24 h and diltiazem plasma concentrations were determined with a sensitive HPLC method. Individual pharmacokinetic parameters, t1/2, t1/2[abs], K, Ka, Tmax, Cmax, Vd/F, Cl/F, AUC0-24 and AUC0- = were calculated. No significant differences were observed in pharmacokinetic parameters between two formulations. The 90% confidence intervals for the test/reference geometric mean ratios of Cmax, AUC0-24 AUC0- = and Cmax/AUC0- = were within the conventional bioequivalence range of 0.8 - 1.25. In-vitro parameters of mean dissolution time [MDT] and time for 70% dissolution [T70] were also determined. There was a significant difference between the MDT for two dosage forms [p<0.0001]. It was concluded that despite of a higher dissolution rate, the test product of diltiazem is bioequivalent to the reference product with respect to the rate and extent of absorption
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Index:
IMEMR (Eastern Mediterranean)
Main subject:
Tablets
/
Biological Availability
/
Therapeutic Equivalency
/
Chemistry, Pharmaceutical
Limits:
Humans
/
Male
Language:
English
Journal:
J. Fac. Pharm. Tehran Univ. Med. Sci.
Year:
2003
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