CKD-828 (80/5mg) Pharmacokinetic Study
- Registration Number
- NCT02250833
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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-amlodipine in health volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 69
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CKD-828(Fixed Dose Combination) CKD-828 FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg Combination Therapy Telmisartan Coadministration of Telmisartan 80mg and S-amlodipine 5mg Combination Therapy S-amlodipine Coadministration of Telmisartan 80mg and S-amlodipine 5mg
- Primary Outcome Measures
Name Time Method Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. up to 168 hours post dose AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. up to 168 hours post dose
- Secondary Outcome Measures
Name Time Method Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. up to 168 hours post dose t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. up to 168 hours post dose AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. up to 168 hours post dose Number of participants with adverse events up to 31days post dose * Adverse Event monitoring
* Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu, Korea, Republic of