Viatris Inc.
The purpose of the present study is to assess prospectively the abuse potential of gabapentin compared to placebo and alprazolam in healthy non-drug-dependent recreational sedative drug users under fasted condition.
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful completion of the Qualification Phase the participants will be enrolled in the Treatment phase. The Treatment Phase is a randomized, double-blind, placebo- and active-controlled, 4 period crossover, single-dose, Williams square design study in healthy male and female adult, non-dependent, recreational sedative users. On Day 1 of each of the Treatment Phase 4 periods, which will be separated by a washout of at least…
Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. At least 20% of participants randomized into the Treatment Phase should be female. 2. Male participants must agree to the following requirements during the intervention period and for at least 93 days after the last dose of study intervention, which corresponds to the time needed to eliminate study intervention(s) plus an additional 90 days (a spermatogenesis cycle): • Refrain from donating sperm. PLUS either: * Be abstinent from heterosexual intercourse as their…
2mg
placebo
1200mg
1800mg
Arctuva estimate
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