A Phase 1 interventional study of DW1029M 1200mg and Metformin 1000mg and Metformin 1000mg in Healthy, sponsored by Dong Wha Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-29.
Sponsored by Dong Wha Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Health services research
Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer
Dong Wha Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1st oral administration of Metformin 1000mg and 2nd oral administration of Metformin 1000mg and DW1029M 1200mg
Drug: DW1029M 1200mg and Metformin 1000mg · Drug: Metformin 1000mg
1st oral administration of DW1029M 1200mg and Metformin 1000mg and 2nd oral administration of Metformin 1000mg
Drug: DW1029M 1200mg and Metformin 1000mg · Drug: Metformin 1000mg
Metformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days
Also known as: Concomitant of DW1029M 1200mg and Metformin 1000mg
Metformin 500mg b.i.d. for 7 days
Also known as: Diabex tab. 500mg
Cmax and AUC
Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)
Time frame: 1d/15d, 5d/19d, 6d/20d : Predose(0,morning), 7d/21d: Predose(0), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 h
Pharmacokinetic Profile of Plasma
Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation\[(Css,max-Css,min)/Css,av\], Swing\[(Css,max-Css,min)/Css,min\]
Time frame: 1d/15d, 5d/19d, 6d/20d: Predose(0, Morning), 7d/21d: Predose(0), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 h
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Dong Wha Pharmaceutical Co. Ltd.