drugset

drugset / Trial / NCT01606059

Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition

NCT01606059 ↗

Phase 1 Completed 30 enrolled Daewon Pharmaceutical Co., Ltd. Chungnam National University Hospital · collab

RandomizedCrossoverOpen-labelSupportive care

Summary

The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.

Timeline

Start: 2012-05
Primary completion: 2012-06
Completion: 2012-06

Publications

Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	325 mg	Oral
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Tramadol	Other / unclassified	37.5 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.