Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/23/2017 |
| Start Date: | June 2016 |
| End Date: | August 2016 |
A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of A High-Fat Meal on the Pharmacokinetics of Bexagliflozin in Healthy Subjects
The purpose of this study is to investigate the effect of a high-fat meal on the levels of
bexagliflozin in the blood in healthy subjects.
bexagliflozin in the blood in healthy subjects.
Inclusion Criteria:
1. Have a Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2.
2. Are willing to use contraception.
3. Are a non-smokers for at least 3 months prior to screening.
4. Are willing and able to stay overnight at a clinical research facility as required by
the protocol.
Exclusion Criteria:
1. Women who are nursing or pregnant.
2. Individuals with a clinically significant history of allergy to drugs or latex.
3. Have a history of alcohol or drug dependence in the last 12 months.
4. Have used prescription or over-the-counter (OTC) drugs within 14 days of receiving the
study drug.
5. Individuals unable (e.g., food intolerance) or unwilling to consume a high-fat
breakfast within 25 minutes.
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