A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
- Registration Number
- NCT02994745
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
- Detailed Description
This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
- A Healthy male aged 19-50 years
- Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
- A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
- A subject who is eligible according to investigator's assessment
Exclusion Criteria
- History or presence of clinically significant medical or psychiatric condition or disease.
- History of gastrointestinal disease and resection
- Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
- Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
- A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
- Positive results for serum examination(HIV, B and C viral test, Syphilis).
- Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- Participation in any other study within 3months.
- History of whole blood donation within 2months and Apheresis 2 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A fixed dose combination group Fimasartan, Atorvastatin A fixed dose combination of Fimasartan/Atorvastatin Co-administration group Fimasartan, Atorvastatin Co-administration of Fimasartan and Atorvastatin
- Primary Outcome Measures
Name Time Method Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin 0~48 hours after medication AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin 0~48 hours after medication
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of