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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

DreamPharma

ClinicalTrials.gov Identifier:

NCT01577849

First received: April 13, 2012

Last updated: NA

Last verified: April 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 13, 2012

Last Updated Date

April 13, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite of pharmacokinetics [ Time Frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]

Cmax, AUClast

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Composite of pharmacokinetics [ Time Frame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]

AUCinf, tmax, t½β

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Vitamin D3
Intervention: Drug: Vitamin D3
Experimental: DP-R206
Intervention: Drug: DP-R206

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

20 to 55 years of healthy volunteers

Exclusion Criteria:

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

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01577849

Other Study ID Numbers ^ICMJE

DP-CTR206-02

Has Data Monitoring Committee

Responsible Party

DreamPharma

Study Sponsor ^ICMJE

DreamPharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Min Gul KIM, MD

Chonbuk National University Hospital

Information Provided By

DreamPharma

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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