Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg
- Registration Number
- NCT01806311
- Lead Sponsor
- HanAll BioPharma Co., Ltd.
- Brief Summary
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Healthy male, Age 20 to 45
- Subject must be willing and able to provide written informed consent to the study.
Exclusion Criteria
- History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
- History of any significant gastrointestinal system and surgery of gastrointestinal.
- History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
- Over 10 tobaccos a day.
- Other condition which in the opinion of the investigator preclude endrollment into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PartA: Candesartan, Candesartan + Amolodipine Candesartan32mg Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally PartB: Amlodipine, Amlodipine+Candesartan Candesartan32mg Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally PartB: Amlodipine, Amlodipine+Candesartan Amlodipine10mg Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally PartA: Candesartan, Candesartan + Amolodipine Amlodipine10mg Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
- Primary Outcome Measures
Name Time Method Part A : AUC, Cmax of Candesartan Over a 24-hour sampling period Par B : AUC, Cmax of Amlodipine Over a 24-hour sampling period
- Secondary Outcome Measures
Name Time Method PartA: Cmin, tmax, CL/F of Candesartan Over a 24-hour sampling period PartB: Cmin, tmax, CL/F of Amlodipine Over a 24-hour sampling period
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the pharmacokinetic interactions between amlodipine and candesartan in healthy volunteers as studied in NCT01806311?
How does the combination of amlodipine and candesartan compare to standard antihypertensive therapies in phase 1 trials?
What biomarkers correlate with blood pressure reduction in calcium channel blocker and angiotensin receptor blocker combinations?
What adverse event profiles are observed in HanAll BioPharma's amlodipine-candesartan combination trials?
How do amlodipine and candesartan synergistically modulate the renin-angiotensin system and calcium channels in hypertension management?
Trial Locations
- Locations (1)
Chungnam national university hospital,clinical trial center
🇰🇷Daejeon, Chungcheongbul-do, Korea, Republic of
Chungnam national university hospital,clinical trial center🇰🇷Daejeon, Chungcheongbul-do, Korea, Republic of