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CompletedNCT01577849Updated Nov 1, 2016

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

A Phase 1 interventional study of Vitamin D3 and DP-R206 in Healthy, sponsored by Alvogen Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Alvogen Korea · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Healthy
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In context

Lead sponsor

Alvogen Korea is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 20 to 55 years of healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Vitamin D3

    Drug: Vitamin D3

  • Experimental
    DP-R206

    Drug: DP-R206

Interventions

  • DrugVitamin D3

    administration of Vitamin D3 24,000 IU

  • DrugDP-R206

    administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)

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What researchers measure

Primary outcomes

  1. Composite of pharmacokinetics

    Cmax, AUClast

    Time frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose

Secondary outcomes

  1. Composite of pharmacokinetics

    AUCinf, tmax, t½β

    Time frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose

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Study locations

1 site
  • Chonbuk national University Hospital
    Jeonju, Chonbuk, Korea, Republic of
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References and documents

Publications

  • 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. PubMed 24378207 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01577849
Lead sponsor
Alvogen Korea
Responsible party
Sponsor
First posted
Apr 16, 2012
Start date
Mar 2012
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Nov 1, 2016

Study contacts

Min Gul KIM, MD
principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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