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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356017
Other study ID # 130HPS11C
Secondary ID
Status Completed
Phase Phase 1
First received May 17, 2011
Last updated September 4, 2011
Start date June 2011
Est. completion date September 2011

Study information

Verified date September 2011
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.


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Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Telmisartan 80mg, S-amlodipine 5mg
Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days)
Telmisartan 80mg
Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Telmisartan AUC 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr No
Secondary Telmisartan Cmax 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr No
Secondary Telmisartan Tmax 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr No
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