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

August 5, 2022 updated by: InventisBio Co., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Labcorp Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 1
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3
EXPERIMENTAL: Sequence 2
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3
EXPERIMENTAL: Sequence 3
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3
EXPERIMENTAL: Sequence 4
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3
EXPERIMENTAL: Sequence 5
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3
EXPERIMENTAL: Sequence 6
3 period, 3 dose level
Drug: D-0502
Formulation 1 Formulation 2 Formulation 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InventisBio Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2021

Primary Completion (ACTUAL)

December 23, 2021

Study Completion (ACTUAL)

May 11, 2022

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (ACTUAL)

February 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • D0502-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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