A Drug-drug Interaction Study of DP-R213

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cholecalciferol; Drug: Cholecalciferol and Raloxifene co-administration; Drug: Raloxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02654093

DP-CTR213-I-02

Details and patient eligibility

About

The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.

Enrollment: 24 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteer, age above 19
• The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion criteria

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study
• Treatment history of other drugs within last 10 days

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Group A

Experimental group

Description:

A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration

Group B

Experimental group

Description:

A → C → B

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration

Group C

Experimental group

Description:

B → A → C

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration

Group D

Experimental group

Description:

B → C → A

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration

Group E

Experimental group

Description:

C → A → B

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration

Group F

Experimental group

Description:

C → B → A

Treatment:

Drug: Raloxifene

Drug: Cholecalciferol

Drug: Cholecalciferol and Raloxifene co-administration