Severance Hospital, Yonsei University
Seoul, 120-752, South Korea
NCT Number: NCT01992601
This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.
The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.
The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.
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Notify Me20 year–50 year
All sexes
Interventional
Phase 1
Seoul, 120-752, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening 7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period.
For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Time frame: 72hr
AUC τ,ss of Rosuvastatin and Telmisartan
Time frame: 72hr
Cmax,ss of Rosuvastatin and Telmisartan
Time frame: 72hr
AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
AUCτ,ss of N-desmetyl Rosuvastatin
Time frame: 72hr
Cmax,ss of N-desmetyl Rosuvastatin
Yuhan Corporation
Industry
Acronym: YH16410 DDI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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