A Drug-drug Interaction Study of DP-R213

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration

• Registration Number: NCT02654093
• Lead Sponsor: Alvogen Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Cholecalciferol	A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
Group A	Cholecalciferol and Raloxifene co-administration	A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
Group B	Cholecalciferol and Raloxifene co-administration	A → C → B
Group C	Cholecalciferol and Raloxifene co-administration	B → A → C
Group D	Cholecalciferol and Raloxifene co-administration	B → C → A
Group F	Raloxifene	C → B → A
Group F	Cholecalciferol and Raloxifene co-administration	C → B → A
Group E	Cholecalciferol	C → A → B
Group E	Raloxifene	C → A → B
Group E	Cholecalciferol and Raloxifene co-administration	C → A → B
Group F	Cholecalciferol	C → B → A
Group A	Raloxifene	A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
Group B	Raloxifene	A → C → B
Group B	Cholecalciferol	A → C → B
Group C	Cholecalciferol	B → A → C
Group C	Raloxifene	B → A → C
Group D	Cholecalciferol	B → C → A
Group D	Raloxifene	B → C → A

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve(AUCt) of raloxifene	0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
AUCt,corr of cholecalciferol	-20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Cmax,corr of cholecalciferol	-20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Peak plasma concentration(Cmax) of raloxifene	0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours

Trial Locations

Locations (1)

Kyungbook National University Hospital; 🇰🇷 Jung-gu, Daegu, Korea, Republic of