A Bioavailability Study on Dronabinol
Phase 1
- Conditions
- THC
- Interventions
- Drug: Chewing Gum
- Registration Number
- NCT03098940
- Lead Sponsor
- Axim Biotechnologies
- Brief Summary
This study is a two part study
- Detailed Description
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.
Exclusion Criteria
- Smokers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Chewing gum Chewing Gum Chewing gum with various doses of dronabinol Capsule (Marinol) Chewing Gum Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol
- Primary Outcome Measures
Name Time Method Bioequivalence up to 48 hours post-dose based on Area under the plasma concentration versus time curve (AUC)
- Secondary Outcome Measures
Name Time Method