Healthy Female Volunteer
Conditions
Brief summary
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects
Detailed description
Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the relative Bioavailability of D-0502 tablet formulation in healthy female subjects
Interventions
Formulation 1 Formulation 2 Formulation 3
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy female subjects between the ages of 18-55 * Required evaluation by Investigator for screening and enrollment * Agreement and compliance with the study and follow-up procedures
Exclusion criteria
* Significant medical history or current comorbidly determined by the Investigator. * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access the oral bioavailability of D-0502 100mg and 200mg tablets | Single Dose, 3 period, 3 treatment study separated by 14 day washout periods to evaluate safety and bioavailability. Overall time in study is approximately 42 days. | Access the oral bioavailability of D-0502 100mg and 200mg tablets relative to D-0502 50mg tablet formulation |
Countries
United States