Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers
Sponsor
Alvogen Korea (Industry)
Overall Status
Completed
CT.gov ID
NCT01577849
Collaborator
(none)
36
1
2
3
11.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
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
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Jun 1, 2012
Actual Study Completion Date
:
Jun 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
|
Outcome Measures
Primary Outcome Measures
- Composite of pharmacokinetics [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 [24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose]
AUCinf, tmax, t½β
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- 20 to 55 years of healthy volunteers
Exclusion Criteria:
- Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alvogen Korea
ClinicalTrials.gov Identifier:
NCT01577849
Other Study ID Numbers:
- DP-CTR206-02
First Posted:
Apr 16, 2012
Last Update Posted:
Nov 1, 2016
Last Verified:
Apr 1, 2012