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

Phase 1 Completed 36 enrolled Alvogen Korea

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2012-03
Primary completion: 2012-06
Completion: 2012-06

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cholecalciferol	Other / unclassified	24000 iu	Oral
Subject	Ibandronate	Other / unclassified	150 mg	Oral

Indications

No indication recorded.