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Completed

NCT Number: NCT02654093

A Drug-drug Interaction Study of DP-R213

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.

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungbook National University Hospital

Jung-gu, Daegu, 41940, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Raloxifene

Drug

Cholecalciferol and Raloxifene co-administration

Drug

Primary outcomes

  1. Area under the plasma concentration versus time curve(AUCt) of raloxifene

    Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours

  2. Peak plasma concentration(Cmax) of raloxifene

    Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours

  3. AUCt,corr of cholecalciferol

    Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours

  4. Cmax,corr of cholecalciferol

    Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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