Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Amlodipine, Valsartan Drug Combination; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Male volunteers in the age between 20 and 55 years old

2. The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9

3. Subjects with no history of any significant chronic disease

4. Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration

5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

1. History of clinically significant allergies including drug allergies

2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease

3. History of genetic muscular disease and family history

4. hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)

5. AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range

6. Creatinine clearance < 80mL/min

7. Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines

8. Serious injury, surgery and acute illness within 4 weeks prior to drug administration

9. History of alcohol, smoking abuse

• alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol

• smoking > 10 cigarettes/day

10. Use of any other medication, including herbal products, within the 2 weeks before dosing

11. Participated in a previous clinical trial within 3 months prior to drug administration

12. Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration

13. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration

14. Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)

15. Subjects considered as unsuitable based on medical judgement by investigators