DP-R213 Phase 1 Pharmacokinetics Study

Summary

A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.

Timeline

Start

2017-01-03

Primary completion

2017-03-08

Completion

2017-03-29

Outcome

Met primary endpoint

paper the area under the concentration-time curve from zero to the last quantifiable time point and the maximum plasma concentration met the regulatory criteria for bioequivalence: PMID 36247744 ↗

paper the corresponding two agents administered concomitantly at respective doses were bioequivalent. PMID 36247744 ↗

Publications

• Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholecalciferol	Other / unclassified	800 iu	—
Subject	DP-R213	Unknown	60 mg	—
Subject	DP-R213	Unknown	800 iu	—
Subject	Raloxifene	Other / unclassified	60 mg	—

Indications

No indication recorded.