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Safety and Pharmacokinetic Characteristics of DP-R206 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: bonviva (Drug)

Phase: Phase 1

Status: Enrolling by invitation

Sponsored by: DreamPharma

Official(s) and/or principal investigator(s):
Kyun seop Bae, M.D., Ph.D., Principal Investigator, Affiliation: Asan Medical Center

Summary

The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd) after oral administration in healthy adult volunteers.

Clinical Details

Official title: Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Ibandronate Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Complex Tablet) and a 150mg Ibandronate Tablet 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 eighty-four. Patients were randomly assigned either a Bonviva tablet(150mg Ibandronate, 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, Bonviva tablet(150mg Ibandronate, qd) second.

Eligibility

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

Criteria:

Inclusion Criteria:

- 20 to 55 years of healthy volunteers

Exclusion Criteria:

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

Locations and Contacts

Asan Medical Center, Seoul, Korea, Republic of
Additional Information

Starting date: August 2011
Last updated: September 5, 2011

Page last updated: August 23, 2015

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