NCT01429675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2011

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 1, 2016

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

August 23, 2011

Last Update Submit

October 31, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Composite of pharmacokinetics

    Cmax, AUClast

    predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose

Secondary Outcomes (1)

  • Composite of pharmacokinetics

    predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose

Study Arms (2)

Bonviva

ACTIVE COMPARATOR
Drug: bonviva

DP-R206

EXPERIMENTAL
Drug: bonviva

Interventions

bonvivaDRUG

150mg Ibandronate once a month

Also known as: DP-R206 : DP11012, bonviva : B1184B01
BonvivaDP-R206

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years of healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Ibandronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Kyun seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

September 7, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

November 1, 2016

Record last verified: 2011-09

Locations

KR(1)