Study design | Treatment doses | Number of subjects | Age range (y) | M/F | Duration of treatment (and follow-up) |
---|---|---|---|---|---|
Single rising oral doses, double-blind, placebo-controlled, randomized | 50, 100, 200, 400, 600 mg | 40 | 21–39 | M | Single dose (1-wk follow-up) |
Repeat rising oral doses, double blind, placebo-controlled, randomized | 50 mg every day, 100 mg every day, 200 mg every day, 100 mg twice a day | 41 | 21–40 | M | 7 d (4 wks follow-up) |
Single dose, food interaction study; open-label randomized | 100 mg every day | 24 | 25–39 | M | Single-dose crossover |