Bioequivalence Study of CJ-30060 in Healthy Volunteers

• Status: Unknown status
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy 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:

• Healthy volunteers aged 20 to 45 years at screening

• BMI: 18~29.9kg/㎡

• Body weight ≥50kg

• Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

• Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease

• Subjects who have symptoms of an acute disease within 28days before first administration

• Subjects who have clinically significant active, chronic disease

• Subjects who fall under the criteria below in laboratory test

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

• Total bilirubin > UNL × 1.5

• CrCL < 50mL/min

• CPK > UNL × 2.5

• Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)

• Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests