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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01429675
First received: August 23, 2011
Last updated: September 5, 2011
Last verified: September 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 DreamPharma:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    AUCinf, tmax, t½β


Estimated Enrollment: 84
Study Start Date: August 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429675

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

No publications provided

Responsible Party: DreamPharma
ClinicalTrials.gov Identifier: NCT01429675     History of Changes
Other Study ID Numbers: DP-CTR206-01
Study First Received: August 23, 2011
Last Updated: September 5, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 17, 2014