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

NCT ID: NCT05226338

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-05-11

Brief Summary

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

Detailed Description

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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

Conditions

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Healthy Female Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Sequence 2

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Sequence 3

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Sequence 4

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Sequence 5

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Sequence 6

3 period, 3 dose level

Group Type EXPERIMENTAL

D-0502

Intervention Type DRUG

Formulation 1 Formulation 2 Formulation 3

Interventions

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D-0502

Formulation 1 Formulation 2 Formulation 3

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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InventisBio Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Labcorp Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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D0502-104

Identifier Type: -

Identifier Source: org_study_id

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