A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
| Registry | NCT02665832 |
|---|---|
| Status | Unknown |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, basic science |
| Enrollment | 58 (Estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (Industry) |
| Conditions | Healthy |
| Interventions | DWJ1351, Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) (Drug) |
| Dates | start 2016-01-01, primary completion 2016-06-01 (estimated), completion 2016-06-01 (estimated), first posted 2016-01-28, last updated 2016-01-28 |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of DWJ1351 All trials of Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AB | Experimental | Drug: DWJ1351; Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) | Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351 |
| BA | Experimental | Drug: DWJ1351; Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) | DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) |
Sex: Male, ages: 19 Years to 50 Years, accepts healthy volunteers
Inclusion Criteria: * Healthy adult male subjects aged 19 to 50 years * Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 * Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results * Subject who provided written informed consent to participate in this study Exclusion Criteria: * Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs * Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease * Subjects who had a serious clinical illness that can impact fate of drugs absorption * Subject who shows vital signs with the number of systolic blood pressure of ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg * Subject who have experienced drug abuse * Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) * Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication