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Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects

Phase 1
Completed
Conditions
Healthy Female Volunteer
Interventions
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
GroupInterventionDescription
Sequence 3D-05023 period, 3 dose level
Sequence 4D-05023 period, 3 dose level
Sequence 1D-05023 period, 3 dose level
Sequence 2D-05023 period, 3 dose level
Sequence 5D-05023 period, 3 dose level
Sequence 6D-05023 period, 3 dose level
Primary Outcome Measures
NameTimeMethod
Access the oral bioavailability of D-0502 100mg and 200mg tabletsSingle 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
NameTimeMethod

Trial Locations

Locations (1)

Labcorp Clinical Research Unit

🇺🇸

Daytona Beach, Florida, United States

Labcorp Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States

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