Viatris Inc.
The purpose of the present study is to assess prospectively the abuse potential of gabapentin when taken with and without oxycodone compared to placebo in healthy non-drug-dependent recreational opioid drug users under fasted condition.
This study consists of a Screening Visit (Visit 1), followed within 28 days by a Qualification Phase (Visit 2) which will require inpatient stay at the clinical research unit (CRU) for 3 nights. After a washout of at least 4 days, eligible participants will enter the Treatment Phase which will include 6 treatment periods with each dosing day separated by a washout period of at least 4 days. Participants will remain residential at the CRU from admission to the Qualification Phase through to completion of the assessments of the last treatment period in the Treatment Phase (approximately 28 days)…
Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. Participants must meet reproductive criteria as outlined in the protocol. 2. Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests. 3. Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at l…
Placebo
oxycodone 20mg
Gabapentin 600 mg
Gabapentin 1200mg
Gabapentin 600 mg + Oxycodone 20 mg
Gabapentin 1200 mg + Oxycodone 20 mg
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