The pharmacokinetics and relative bioavailability of diltiazem hydrochloride controlled-release capsule in healthy volunteers

HE Lin;WNG Jin-xin;LI Tong-ling;CHENG Qing;LI Tun

Chinese Pharmaceutical Journal ›› 2000, Vol. 35 ›› Issue (09) : 606-610.

Chinese Pharmaceutical Journal ›› 2000, Vol. 35 ›› Issue (09) : 606-610.
临床药学

The pharmacokinetics and relative bioavailability of diltiazem hydrochloride controlled-release capsule in healthy volunteers

  • HE Lin,WANG Jian-xin,LI Tong-ling,CHENG Qiang,LI Tun
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Abstract

OBJECTIVE To study the pharmacokinetics and relative bioavailability of diltiazem hydrochloride controlled-release (DTZ-CR) capsule in healthy male volunteers.METHODS Diltiazem tablet was used as the refereace.A crossover self-control study of single and multiple dose was conducted on 12 healthy volunteers.Plasma concentrations were determined by HPLC.RESULTS The pharmacokinetic parameters after a single dose of 60 mg DTZ-CR capsule were: AUC0→τ=(637.56±106.18) h·μg·L-1,cmax=(59.5±8.0) μg·L-1,tmax(4.5±0.5) h,t1/2=(5.9±1.1) h,respectively.The relative bioavailability was (106.39±12.53)%.The degree of fluctuation for steady state of multipledoses was (0.89±0.11) μg·L-1,which were significantly lower than that of the reference tablet.CONCLUSION The two formulations were of bioequivalence and DTZ-CR capsule had marked characteristics of controlled release.

Key words

diltiazem / pharmacokinetics / bioavailability / HPLC

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HE Lin;WNG Jin-xin;LI Tong-ling;CHENG Qing;LI Tun. The pharmacokinetics and relative bioavailability of diltiazem hydrochloride controlled-release capsule in healthy volunteers[J]. Chinese Pharmaceutical Journal, 2000, 35(09): 606-610

References

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