Absolute Bioavailability Study With Bexagliflozin
| Status: | Withdrawn |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/27/2018 |
| Start Date: | August 1, 2018 |
| End Date: | September 16, 2018 |
A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects
The purpose of this study is to determine the absolute bioavailability of bexagliflozin
following a single oral dose co-administered with an intravenous dose.
following a single oral dose co-administered with an intravenous dose.
Inclusion Criteria:
- body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- no nicotine and tobacco consumption in the past 3 months
- willing and able to be confined to the clinical research facility as required by the
protocol
Exclusion Criteria:
- clinically significant history of allergy to drugs or latex
- history of alcohol or drug dependence in the past 12 months.
- donation of a significant amount of blood in the past 2 months
- willing to use an adequate form of birth control during the study and for 90 days
after discharge from clinic
- exposure to investigational drug in the past 30 days or 7 half-lives of the
investigational drug, whichever is longer
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