A single-center, open-label, single-dose study investigating the safety, tolerability, and pharmacokinetic properties of nalmefene 10 mg tablets in healthy Japanese male subjects
- Conditions
- Healthy adult male
- Registration Number
- JPRN-jRCT2080223097
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 7
The subject is able to read and understand the informed consent form (ICF).
- The subject has a body mass index (BMI) between 19 and 25 kg/m2 (inclusive) at the screening visit.
- The subject has a resting pulse and heart rate (as read on the ECG) between 45 and 100 bpm (inclusive) at the screening visit.
- The subject has taken any prescription drugs, over-thecounter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1.
- The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits).
- The subject has taken any investigational products within 4 months prior to Day 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, tolerability, and pharmacokinetics
- Secondary Outcome Measures
Name Time Method