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

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ClinicalTrials.gov Identifier: NCT01577849
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

April 13, 2012
April 16, 2012
November 1, 2016
March 2012
June 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01577849 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Vitamin D3
    administration of Vitamin D3 24,000 IU
  • Drug: DP-R206
    administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)
  • Active Comparator: Vitamin D3
    Intervention: Drug: Vitamin D3
  • Experimental: DP-R206
    Intervention: Drug: DP-R206
Jeon JY, Lee SY, Im YJ, Kim EY, Kim Y, Park TS, Chae SW, Lee JW, Jun H, Lee TW, Kim MG. Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults. Clin Ther. 2014 Jan 1;36(1):48-57. doi: 10.1016/j.clinthera.2013.12.001. Epub 2013 Dec 28. Erratum in: Clin Ther. 2014 Mar 1;36(3):456-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Same as current
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01577849
DP-CTR206-02
No
Not Provided
Not Provided
Alvogen Korea
Alvogen Korea
Not Provided
Principal Investigator: Min Gul KIM, MD Chonbuk National University Hospital
Alvogen Korea
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP