Verified March 2017 by Axim Biotechnologies
Sponsor:
Information provided by (Responsible Party):
Axim Biotechnologies
ClinicalTrials.gov Identifier:
NCT03098940
First received: March 21, 2017
Last updated: March 28, 2017
Last verified: March 2017
This study is a two part study
| THC | Drug: Chewing Gum | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers |
| Estimated Enrollment: | 50 |
| Anticipated Study Start Date: | January 2018 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Experimental: Chewing gum
Chewing gum with various doses of dronabinol |
Drug: Chewing Gum
During the study healthy subjects will receive single doses of the various strengths of dronabinol |
| Active Comparator: Capsule (Marinol)
Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol |
Drug: Chewing Gum
During the study healthy subjects will receive single doses of the various strengths of dronabinol |
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
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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:
No Contacts or Locations Provided
| Responsible Party: | Axim Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT03098940 History of Changes |
| Other Study ID Numbers: | MedChew |
| Study First Received: | March 21, 2017 |
| Last Updated: | March 28, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
| Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on April 05, 2017