NCT01429675

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Alvogen Korea · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	bonviva	150mg Ibandronate once a month

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-09-07
• Last updated: 2016-11-01

Locations

1 site across 1 country: South Korea