Dyslipidemia (Fredrickson Type ?a) Clinical Trial
Official title:
Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers
| Verified date | March 2014 |
| Source | Chong Kun Dang Pharmaceutical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 29, 2014 |
| Est. primary completion date | April 7, 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 19 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - A healthy male volunteer between 19 and 55 years old. - BMI between 18.5 and 27. - Able to participate in the entire trial - Signed the informed consent form prior to study participation. Exclusion Criteria: - Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system - sit SBP < 100mmHg or sit SBP = 150mmHg or sit DBP < 70mmHg or sit DBP = 100mmHg - Have acute infection history within 14 days - Have a allergic disease of need to treat - Have hypersensitivity reactions history for IP or any specific drugs. - AST, ALT or Total bilirubin > UNL * 1.5 - Estimated GFR < 60 ml/min - Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption - A heavy smoker (cigarette > 10 cigarettes per day) - A heavy alcohol consumer (alcohol > 140g/week) - A heavy grapefruit consumer (more than 1cup per a day) - Have a history of drug abuse or showed a positive for urine drug test. - Administrated IP within 60 days prior to screening - Rhabdomyolysis include of having a history or family history of genetic muscle diseases - Positive for HIV antibody, HBsAg, HCV antibody test - Previously donate whole blood within 60 days or component blood within 30 days - Subject takes ethical drug or herbal medicine within 30 days - Clinically significant laboratory test result - An impossible one who participates in clinical trial by investigator's decision including other reason |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Chong Kun Dang Pharmaceutical |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUCt, Cmax,ss of fenofibric acid and atorvastatin | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h | ||
| Secondary | Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h |