PHARMACOKINETICS AND COMPARATIVE BIOAVAILABILITY OF TWO DILTIAZEM TABLET FORMULATIONS IN HEALTHY VOLUNTEERS

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DADASHZADEH S.; ZARGHI A.; EBRAHIMIAN A.J.

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Journal Paper

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Journal: DARU Journal of Pharmaceutical Sciences Year:2003 | Volume:11 | Issue:1 Page(s): 14-18

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Information Journal Paper

Title

PHARMACOKINETICS AND COMPARATIVE BIOAVAILABILITY OF TWO DILTIAZEM TABLET FORMULATIONS IN HEALTHY VOLUNTEERS

Author(s)

DADASHZADEH S. | ZARGHI A. | EBRAHIMIAN A.J. | Issue Writer Certificate

Keywords

BIOEQUIVALENCE

DILTIAZEM

DISSOLUTION

PHARMACOKINETICS

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 (T7o) 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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APA: Copy

DADASHZADEH, S., ZARGHI, A., & EBRAHIMIAN, A.J.. (2003). PHARMACOKINETICS AND COMPARATIVE BIOAVAILABILITY OF TWO DILTIAZEM TABLET FORMULATIONS IN HEALTHY VOLUNTEERS. DARU JOURNAL OF PHARMACEUTICAL SCIENCE, 11(1), 14-18. SID. https://sid.ir/paper/275199/en

Vancouver: Copy

DADASHZADEH S., ZARGHI A., EBRAHIMIAN A.J.. PHARMACOKINETICS AND COMPARATIVE BIOAVAILABILITY OF TWO DILTIAZEM TABLET FORMULATIONS IN HEALTHY VOLUNTEERS. DARU JOURNAL OF PHARMACEUTICAL SCIENCE[Internet]. 2003;11(1):14-18. Available from: https://sid.ir/paper/275199/en

IEEE: Copy

S. DADASHZADEH, A. ZARGHI, and A.J. EBRAHIMIAN, “PHARMACOKINETICS AND COMPARATIVE BIOAVAILABILITY OF TWO DILTIAZEM TABLET FORMULATIONS IN HEALTHY VOLUNTEERS,” DARU JOURNAL OF PHARMACEUTICAL SCIENCE, vol. 11, no. 1, pp. 14–18, 2003, [Online]. Available: https://sid.ir/paper/275199/en

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