Status:
COMPLETED
CKD-828 (80/5mg) Pharmacokinetic Study
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-aml...
Eligibility Criteria
Inclusion
- A healthy volunteer between 20 and 55 years old
- More than 50kg and within 20% of ideal body weight
- No any congenital or chronic diseases and medical symptom
- Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
- Signed the informed consent form prior to the study participation.
Exclusion
- History of relevant hypersensitivity against drug
- Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
- Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \> 1.5\*ULN)
- SBP \<90mmHg or SBP \>150mmHg
- DBP \<50mmHg or DBP \>100mmHg
- Creatinine clearance \<80mL/min
- A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
- The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
- A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
- Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
- Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02250833
Start Date
September 1 2014
End Date
December 1 2014
Last Update
April 10 2015
Active Locations (1)
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1
Kyungpook National University Hospital
Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, South Korea, 700-721