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- Title
PIII-41.
- Authors
Kim, B. H.; Kim, J. R.; Lim, K. S.; Kim, J. W.; Cho, S. J.; Yu, K. S.; Shin, S. G.; Jang, I. J.
- Abstract
Background/aims: Pregabalin has pain-relieving, anxiolytic, and anticonvulsant activity. Our objective was to determine the pharmacokinetic characteristics, safety, and tolerance of rising, single oral doses of pregabalin capsules (100, 200, and 300 mg) in healthy Korean volunteers.Methods: An oral, rising, single-dose, double-blind, randomized, placebo-controlled, parallel group, staggered-start study was conducted in 30 healthy male volunteers. Serial blood and urine samples were collected for pregabalin assay from Day 1 to 3. Safety evaluations were performed. Pharmacokinetic parameters were determined using noncompartmental methods.Results: Pregabalin was rapidly absorbed with individual tmax values ranging from 0.5 to 2 hr. Mean oral bioavailability was at least 94.5%. Mean values by dose group for renal clearance and oral clearance were similar. Values for t½ were independent of dose, ranging from 5 to 8 hr for individual subjects. Pregabalin Cmax and AUC(0-∞) appeared to increase less than proportionally with dose, possibly due to differences between subject groups. All Adverse Events (AEs) were mild and transient; the most common AE was dizziness. No clinically significant laboratory abnormalities, vital signs or ECG measurements were observed.Conclusions: Pregabalin Cmax and AUC values increased with increasing dose; however, the increases were slightly less than dose proportional. Pregabalin was generally safe and well tolerated with only mild AEs.Clinical Pharmacology & Therapeutics (2005) 79, P69–P69; doi: 10.1016/j.clpt.2005.12.249
- Subjects
PHARMACEUTICAL research; PHARMACOKINETICS; PHARMACOLOGY; ANTICONVULSANTS; PLACEBOS
- Publication
Clinical Pharmacology & Therapeutics, 2006, Vol 79, Issue 2, pP69
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1016/j.clpt.2005.12.249