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OpenTrials
Completed

NCT Number: NCT01429675

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

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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 to 55 years of healthy volunteers

Exclusion criteria

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

Treatment and study plan

bonviva

Drug

150mg Ibandronate once a month

Other names: DP-R206 : DP11012, bonviva : B1184B01

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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