A Drug-drug Interaction Study of DP-R213

NCT02654093 | Completed Phase 1

• 1 other identifier: DP-CTR213-I-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• Peak plasma concentration(Cmax) 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

Study Arms (6)

Group A

EXPERIMENTAL

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

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

Group B

EXPERIMENTAL

A → C → B

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

Group C

EXPERIMENTAL

B → A → C

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

Group D

EXPERIMENTAL

B → C → A

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

Group E

EXPERIMENTAL

C → A → B

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

Group F

EXPERIMENTAL

C → B → A

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

Interventions

Cholecalciferol DRUG

Group A; Group B; Group C; Group D; Group E; Group F

Raloxifene DRUG

Group A; Group B; Group C; Group D; Group E; Group F

Cholecalciferol and Raloxifene co-administration DRUG

Group A; Group B; Group C; Group D; Group E; Group F

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvogen Korea: lead

Study Sites (1)

Kyungbook National University Hospital

Jung-gu, Daegu, 41940, South Korea

Location

Related Publications (1)

• Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4.

  PMID: 34984851 DERIVED

MeSH Terms

Interventions

Cholecalciferol; Raloxifene Hydrochloride

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 13, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)