Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg 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; Amlodipine, Valsartan Drug Combination; Rosuvastatin Calcium; Valsartan

Criteria

Inclusion Criteria:

• Healthy male aged 20 to 45 years at the screening

• Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)

• Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria:

• Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.

• Subject who have symptoms, result from acute disease within 28days before first administration.

• Subject who have chronic persisting disease with clinical significance.

• Subject who fall under the criteria below in laboratory test.

• AST/ALT > UNL (upper normal limit) x 2

• Total bilirubin > UNL x 1.5

• In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault

• CPK > UNL x 2.5

• Subject who with low blood pressure with clinical significance at screening test.

(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)

• Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.