NCT01577849

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 1, 2016

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

April 13, 2012

Last Update Submit

October 31, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Composite of pharmacokinetics

    Cmax, AUClast

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

Secondary Outcomes (1)

  • Composite of pharmacokinetics

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

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR
Drug: Vitamin D3

DP-R206

EXPERIMENTAL
Drug: DP-R206

Interventions

Vitamin D3DRUG

administration of Vitamin D3 24,000 IU

Vitamin D3
DP-R206DRUG

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

DP-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)

Chonbuk national University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Related Publications (1)

  • Jeon JY, Lee SY, Im YJ, Kim EY, Kim Y, Park TS, Chae SW, Lee JW, Jun H, Lee TW, Kim MG. Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults. Clin Ther. 2014 Jan 1;36(1):48-57. doi: 10.1016/j.clinthera.2013.12.001. Epub 2013 Dec 28.

    PMID: 24378207DERIVED

MeSH Terms

Interventions

CholecalciferolDP-R206

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Min Gul KIM, MD

    Chonbuk National University Hospital

    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

April 13, 2012

First Posted

April 16, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 1, 2016

Record last verified: 2012-04

Locations

KR(1)