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

NCT ID: NCT01429675

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Bonviva

Group Type ACTIVE_COMPARATOR

bonviva

Intervention Type DRUG

150mg Ibandronate once a month

DP-R206

Group Type EXPERIMENTAL

bonviva

Intervention Type DRUG

150mg Ibandronate once a month

Interventions

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bonviva

150mg Ibandronate once a month

Intervention Type DRUG

Other Intervention Names

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DP-R206 : DP11012 bonviva : B1184B01

Eligibility Criteria

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Inclusion Criteria

* 20 to 55 years of healthy volunteers

Exclusion Criteria

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyun seop Bae, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DP-CTR206-01

Identifier Type: -

Identifier Source: org_study_id