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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: bonviva

• Registration Number: NCT01429675
• Lead Sponsor: Alvogen Korea

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-05
• Study First Posted: 2011-09-07
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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
Bonviva	bonviva	-
DP-R206	bonviva	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of