A Phase 1 interventional study of CKD-397 and TD+TM in Benign Prostatic Hyperplasia, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment
The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.
A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 36 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tadalafil/ Tamsulosin Fixed dose combination
Drug: CKD-397
Tadalafil/ Tamsulosin Coadministration
Drug: TD+TM
Arm A:Tamsulosin/ Tadalafil Fixed dose combination
Also known as: Arm A
Arm B: Tamsulosin/ Tadalafil Coadministration
Also known as: Arm B
AUC0-t of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCinf of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
CL/F of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Vd/F of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Chong Kun Dang Pharmaceutical