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

Phase 1

Completed

• Conditions: Hyperlipidemias; Hypertension
• Interventions: Drug: CJ-30060; Drug: Exforge tab 5/160mg, Crestor tab 10mg

• Registration Number: NCT03009474
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Detailed Description

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exforge tab 5/160mg, Crestor tab 10mg	CJ-30060	Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
CJ-30060	Exforge tab 5/160mg, Crestor tab 10mg	Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Half life (t1/2) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of