Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers

Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Vitamin D3 Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Tablet) and a 24,000 IU Vitamin D3 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01577849

Enrollment

Registered

2012-04-16

Start date

2012-03-31

Completion date

2012-06-30

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 to compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 , qd) after oral administration in healthy adult volunteers.

Detailed description

The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3 tablet(24,000 IU Vitamin D3, 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, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.

Interventions

DRUGVitamin D3

administration of Vitamin D3 24,000 IU

DRUGDP-R206

administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)

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	24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose	Cmax, AUClast

Secondary

Measure	Time frame	Description
Composite of pharmacokinetics	24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose	AUCinf, tmax, t½β

Countries

South Korea

Outcome results

None listed

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