In:
Journal of Pharmacy and Pharmacology, Oxford University Press (OUP), Vol. 64, No. 3 ( 2012-02-06), p. 337-343
Abstract:
To investigate the safety, pharmacokinetics and food effect of iptakalim in healthy adult Han Chinese volunteers. Methods Study 1 was a randomized open-label, Latin square designed, single-dose, three-period, self-control crossover study. Six men and six women received 5, 10 and 20 mg of iptakalim orally. Study 2 was a randomized, open-label, single-dose, two-period, self-control crossover study. Ten men were included and each subject received 5 mg iptakalim orally, fasting and nonfasting. Key findings No adverse effects were reported and no clinically meaningful changes in vital signs were found. Cmax, AUC0–t and AUC0–∞ were proportional over the dose levels of 5, 10 and 20 mg. Tmax, t½ and CL/F were similarly independent of dose level. In the 5 mg and 20 mg group, the Cmax, AUC0–t and AUC0–∞ in women were significantly higher than in men, although they showed no difference after correction by mg/kg doses in the 5 mg group. At the 5-mg dose level, no significant difference in pharmacokinetics was found in nonfasting and fasting subjects. Conclusions Single-dose pharmacokinetics of iptakalim showed dose proportionality over the dose levels of 5–20 mg. The pharmacokinetics showed gender differences in the 5 and 20 mg groups. Food had almost no impact on the pharmacokinetics at the 5 mg level.
Type of Medium:
Online Resource
ISSN:
2042-7158
,
0022-3573
DOI:
10.1111/j.2042-7158.2011.01411.x
Language:
English
Publisher:
Oxford University Press (OUP)
Publication Date:
2012
detail.hit.zdb_id:
2041988-0
detail.hit.zdb_id:
2050532-2
SSG:
15,3
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