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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01429675

Enrollment

105

Registered

2011-09-07

Start date

2011-08-31

Completion date

2012-03-31

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

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.

Interventions

DRUGbonviva

150mg Ibandronate once a month

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 to 55 years of healthy volunteers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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	Cmax, AUClast

Secondary

Measure	Time frame	Description
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	AUCinf, tmax, t½β

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026