Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02127320
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male volunteer, age 19~45 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Exclusion Criteria
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Rosuvastatin 20mg Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 2 Rosuvastatin 20mg + Ezetimibe 10mg Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg Sequence 5 Rosuvastatin 20mg Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 5 Rosuvastatin 20mg + Ezetimibe 10mg Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 3 Rosuvastatin 20mg Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg Sequence 1 Ezetimibe 10mg Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 3 Ezetimibe 10mg Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg Sequence 3 Rosuvastatin 20mg + Ezetimibe 10mg Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg Sequence 4 Rosuvastatin 20mg + Ezetimibe 10mg Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg Sequence 6 Rosuvastatin 20mg + Ezetimibe 10mg Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg Sequence 1 Rosuvastatin 20mg + Ezetimibe 10mg Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 2 Ezetimibe 10mg Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg Sequence 2 Rosuvastatin 20mg Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg Sequence 5 Ezetimibe 10mg Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg Sequence 4 Ezetimibe 10mg Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg Sequence 6 Rosuvastatin 20mg Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg Sequence 6 Ezetimibe 10mg Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg Sequence 4 Rosuvastatin 20mg Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg
- Primary Outcome Measures
Name Time Method Rosuvastatin AUCτ,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Ezetimibe AUCτ,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Rosuvastatin Cmax,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Ezetimibe Cmax,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
- Secondary Outcome Measures
Name Time Method Rosuvastatin Tmax,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Rosuvastatin t1/2β 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Ezetimibe Tmax,ss 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h Ezetimibe t1/2β 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of, Korea, Republic of