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Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01577849
First received: April 13, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 , qd) after oral administration in healthy adult volunteers.


Condition Intervention Phase
Healthy
 Drug: Vitamin D3
Drug: DP-R206
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Vitamin D3 Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Tablet) and a 24,000 IU Vitamin D3 in Healthy Adult Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by DreamPharma:

Primary Outcome Measures:
  • Composite of pharmacokinetics [ Time Frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
    Cmax, AUClast


Secondary Outcome Measures:
  • Composite of pharmacokinetics [ Time Frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
    AUCinf, tmax, t½β


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 Drug: Vitamin D3
administration of Vitamin D3 24,000 IU
Experimental: DP-R206 Drug: DP-R206
administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)

Detailed Description:

The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3 tablet(24,000 IU Vitamin D3, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577849

Locations
Korea, Republic of
Chonbuk national University Hospital
Jeonju, Chonbuk, Korea, Republic of
Sponsors and Collaborators
DreamPharma
Investigators
Principal Investigator: Min Gul KIM, MD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: DreamPharma
ClinicalTrials.gov Identifier: NCT01577849     History of Changes
Other Study ID Numbers: DP-CTR206-02
Study First Received: April 13, 2012
Last Updated: April 13, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013