Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects
- Registration Number
- NCT05226338
- Lead Sponsor
- InventisBio Co., Ltd
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 3 D-0502 3 period, 3 dose level Sequence 4 D-0502 3 period, 3 dose level Sequence 1 D-0502 3 period, 3 dose level Sequence 2 D-0502 3 period, 3 dose level Sequence 5 D-0502 3 period, 3 dose level Sequence 6 D-0502 3 period, 3 dose level
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States
Labcorp Clinical Research Unit🇺🇸Daytona Beach, Florida, United States