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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577849
First Posted: April 16, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alvogen Korea
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Alvogen Korea:

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 ]
    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 ]
    AUCinf, tmax, t½β


Enrollment: 36
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577849


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT01577849     History of Changes
Other Study ID Numbers: DP-CTR206-02
First Submitted: April 13, 2012
First Posted: April 16, 2012
Last Update Posted: November 1, 2016
Last Verified: April 2012

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


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