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

Information source: DreamPharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Vitamin D3 (Drug); DP-R206 (Drug)

Phase: Phase 1

Status: Enrolling by invitation

Sponsored by: DreamPharma

Official(s) and/or principal investigator(s):
Min Gul KIM, MD, Principal Investigator, Affiliation: Chonbuk National University Hospital


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Composite of pharmacokinetics

Secondary outcome: Composite of pharmacokinetics

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.


Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- 20 to 55 years of healthy volunteers

Exclusion Criteria:

- Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)

Locations and Contacts

Chonbuk national University Hospital, Jeonju, Chonbuk, Korea, Republic of
Additional Information

Starting date: March 2012
Last updated: April 13, 2012

Page last updated: August 23, 2015

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