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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014