Single-Dose Pharmacokinetics of Fiduxosin under Fasting Conditionsin Healthy Elderly Male Volunteers
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Clin Drug Invest 2002; 22 (7): 463-467 1173-2563/02/0007-0463/$25.00/0 © Adis International Limited. All rights reserved.
Single-Dose Pharmacokinetics of Fiduxosin under Fasting Conditions in Healthy Elderly Male Volunteers Sandeep Dutta, Yiming Zhang, Daniel J. Daszkowski, G. Richard Granneman and Marleen Verlinden Abbott Laboratories, Abbott Park, Illinois, USA
Benign prostatic hyperplasia (BPH) is the most common cause of voiding dysfunction in middleaged and elderly males.[1] The prevalence of BPH increases with age. Epidemiological data indicate that the incidence of histological BPH is as high as 50% in men aged 60 years, rising to 88% in men aged 80 years.[2] Clinical data suggest that the use of a selective α1A-adrenoceptor antagonist results in clinical benefit.[2-4] Fiduxosin is a novel orally active agent that is a selective α1A-adrenoceptor antagonist.[5-7] Since the intended use of fiduxosin is in a middle-aged/elderly male population, the pharmacokinetics of single doses of fiduxosin were evaluated in a first-in-human study conducted using healthy elderly (≥60 years) male volunteers. Study Participants and Methods Subjects
Study participants were healthy nonsmoking males at least 60 years of age and within 20% of the upper and lower boundaries of bodyweight set forth in the Metropolitan Life Insurance Table. Subjects were judged to be in good health based on the results of medical history, physical examination, vital signs, electrocardiogram and routine clinical laboratory evaluations. Study candidates had not taken any prescription and over-thecounter medications within 2 weeks prior to study drug administration. In the screening period prior to drug administra-
tion, candidates received a full explanation of the study and underwent prestudy procedures. All enrollees gave written, informed consent, as approved by the ethics committee at U-Gene Research BV, Utrecht, The Netherlands, prior to study participation. Study Design
This was a Phase I, randomised, double-blind, placebo-controlled, single-centre study. Thirty-six healthy elderly subjects were enrolled in the study and randomised into three dose groups of equal size. Within each group of 12 volunteers, eight subjects were randomised to receive fiduxosin (Abbott Laboratories, Abbott Park, IL) and four subjects to receive matching placebo. The double-blind treatment phase consisted of four drug administration periods for group 1 and three drug administration periods for groups 2 and 3. Group 1 volunteers received four single doses of 2, 20, 60 and 130mg fiduxosin or placebo. Group 2 subjects received three single doses of 5, 30 and 80mg fiduxosin or placebo. Group 3 participants received three single doses of 10, 40 and 100mg fiduxosin or placebo. All doses were administered orally with 180ml of water after an 8-hour fast and the first post-dose meal was consumed approximately 2 hours after drug administration. Drug administration for the three groups in each period was separated by at least 3 days, and within each
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