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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Vitamin D3; Drug: DP-R206

• Registration Number: NCT01577849
• Lead Sponsor: Alvogen Korea

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 Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 20 to 55 years of healthy volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	-
DP-R206	DP-R206	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonbuk national University Hospital; 🇰🇷 Jeonju, Chonbuk, Korea, Republic of