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This study is a two part study
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing gum | Experimental | Chewing gum with various doses of dronabinol |
|
| Capsule (Marinol) | Active Comparator | Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewing Gum | Drug | During the study healthy subjects will receive single doses of the various strengths of dronabinol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence | based on Peak Plasma Concentration (Cmax) | up to 48 hours post-dose |
| Bioequivalence | based on Area under the plasma concentration versus time curve (AUC) | up to 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |