Winchell et al77
A series of open-label, three-period, randomized,
crossover studies
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1. 24 healthy young subjects (mean age: 25.5 years; range: 19-39 years;
16 males and 8 females)
2. 18 healthy subjects (mean age: 28.7 years; range: 22-40 years; 8
males, 10 females)
3. 12 older subjects (mean age: 71.3 years; range: 65-79 years; 6 males,
6 females)
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To investigate the pharmacokinetics and bioavailability of
cyclobenzaprine, including the effects of age and hepatic
insufficiency
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1. Subjects received
5 mg orally or 1.25 mg IV cyclobenzaprine
2. Subjects received a single oral dose of 2.5, 5, or 10 mg
cyclobenzaprine
on Day 1 then every 8 hours from Days 8
through 14 and a final dose on Day 15
3. Subjects received 5 mg cyclobenzaprine orally three times daily for 7
days and a final dose on the 8th day
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3. Cyclobenzaprine plasma concentrations after multiple dosing were
significantly higher for the older compared to young subjects
- After the first dose, plasma concentration profiles were similar in
older and young subjects
- Mean accumulation ratio was 7.9 for older subjects compared to 4.3 for
young subjects, and mean effective T1/2 was 33.4 h
(range: 20.0-53.4 h) in older subjects compared to 18.4 h (range:
9.3-41.3 h) in young subjects
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Malhotra et al97
Two randomized double-blind placebo-controlled trials
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1. 32 healthy males aged 18-45
2. 16 young men, 16 older men and 16 older women
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To examine the effect of age, sex and race on the pharmacokinetics,
pharmacodynamics and safety profiles of fesoterodine
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Subjects received either 8 mg of fesoterodine extended release or
matching placebo with blood samples drawn over 36 h after drug
administration
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Renal clearance was 28% lower in older men and women than younger
men
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