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Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429675
First Posted: September 7, 2011
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alvogen Korea
  Purpose
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.

Condition Intervention Phase
Healthy Drug: bonviva Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Alvogen Korea:

Primary Outcome Measures:
  • Composite of pharmacokinetics [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose ]
    Cmax, AUClast


Secondary Outcome Measures:
  • Composite of pharmacokinetics [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose ]
    AUCinf, tmax, t½β


Enrollment: 105
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bonviva Drug: bonviva
150mg Ibandronate once a month
Other Names:
  • DP-R206 : DP11012
  • bonviva : B1184B01
Experimental: DP-R206 Drug: bonviva
150mg Ibandronate once a month
Other Names:
  • DP-R206 : DP11012
  • bonviva : B1184B01

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429675


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Alvogen Korea
Investigators
Principal Investigator: Kyun seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT01429675     History of Changes
Other Study ID Numbers: DP-CTR206-01
First Submitted: August 23, 2011
First Posted: September 7, 2011
Last Update Posted: November 1, 2016
Last Verified: September 2011

Additional relevant MeSH terms:
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs