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

InventisBio

Status and phase: Completed; Phase 1

Conditions: Healthy Female Volunteer

Treatments: Drug: D-0502

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226338

D0502-104

Details and patient eligibility

About

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

Full 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

Enrollment: 18 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sequence 1

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502

Sequence 2

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502

Sequence 3

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502

Sequence 4

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502

Sequence 5

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502

Sequence 6

Experimental group

Description:

3 period, 3 dose level

Treatment:

Drug: D-0502