Key result
Single oral diltiazem yields dose-dependent AUC increases with similar half-life and tmax across doses.
Why the study?
Oral diltiazem is increasingly used for Prinzmetal's angina, but its pharmacokinetics and pharmacology in normal volunteers needed investigation.
What are the pharmacokinetic properties, electrocardiographic effects, and blood pressure responses of single oral doses of diltiazem in normal male volunteers?
What are the pharmacokinetic properties, electrocardiographic effects, and blood pressure responses of single oral doses of diltiazem in normal male volunteers?
Single oral doses of diltiazem demonstrate dose-dependent increases in AUC with consistent half-life and tmax in healthy male volunteers.
Oral diltiazem is being used increasingly in the treatment of Prinzmetal's angina. This study investigated the pharmacokinetics, electrocardiographic effects, and blood pressure responses of normal male volunteers to various single oral doses of diltiazem. Doses selected were 30, 60, 90, and 120 mg. Thirteen subjects received 30 mg. 12 subjects received 60 mg, 10 subjects received 90 mg diltiazem, and four subjects received 120 mg diltiazem AUCs for the 60, 90, and 120 mg doses were 565, 984, and 1258 ng/ml . hr, respectively. The values for t1/2, beta, and tmax were similar after each dosing.
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Kinney et al. (1981) studied Healthy volunteers (n=39). Oral diltiazem was evaluated on Pharmacokinetics (AUC, t1/2, beta, tmax). Single oral doses of diltiazem (60, 90, and 120 mg) in normal male volunteers yielded AUCs of 565, 984, and 1258 ng/ml.hr, respectively, with similar t1/2, beta, and tmax across doses.
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