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Completed

NCT Number: NCT05226338

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

Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects

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Key information

Conditions

Healthy Female Volunteer

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit

Daytona Beach, Florida, 32114, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-0502

Drug

Formulation 1 Formulation 2 Formulation 3

Primary outcomes

  1. Access the oral bioavailability of D-0502 100mg and 200mg tablets

    Time frame: 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

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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