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

A Phase 1, Open-Label, Randomized, Single Dose, 3-Period, 3-Treatment Study to Evaluate the Relative Bioavailability of D-0502 Tablet Formulations in Healthy Female Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226338
Enrollment
18
Registered
2022-02-07
Start date
2021-10-27
Completion date
2022-05-11
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Female Volunteer

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

DRUGD-0502

Formulation 1 Formulation 2 Formulation 3

Sponsors

InventisBio Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026