Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: Exforge® tab 10/160mg, Crestor® tab 20mg; Drug: CJ-30060 10/160/20mg

• Registration Number: NCT03639493
• Lead Sponsor: HK inno.N Corporation

Brief Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg 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® 10/160mg, Crestor® 20mg in healthy male volunteers.

Study Timeline

• Study Start: 2018-04-06
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-17
• Status Verified: 2018-08
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy males aged 20 to 45 years at screening
• BMI: 18 ~ 29.9kg/m^2
• 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 28 days 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) x 2
  • Total bilirubin > UNL x 1.5
  • CrCL < 50mL/min
  • CPK > UNL x 2.5

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

• Subjects 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
Sequence 1	Exforge® tab 10/160mg, Crestor® tab 20mg	* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg * Period 2: receive CJ-30060 10/160/20mg
Sequence 1	CJ-30060 10/160/20mg	* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg * Period 2: receive CJ-30060 10/160/20mg
Sequence 2	CJ-30060 10/160/20mg	* Period 1: receive CJ-30060 10/160/20mg * Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg
Sequence 2	Exforge® tab 10/160mg, Crestor® tab 20mg	* Period 1: receive CJ-30060 10/160/20mg * Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg

Primary Outcome Measures

Name	Time	Method
Cmax of amlodipine	Up to 144 hours post-dose
Cmax of valsartan	Up to 144 hours post-dose
Cmax of rosuvastatin	Up to 144 hours post-dose
AUClast of valsartan	Up to 144 hours post-dose
AUClast of amlodipine	Up to 144 hours post-dose
AUClast of rosuvastatin	Up to 144 hours post-dose

Secondary Outcome Measures

Name	Time	Method
AUCinf of amlodipine, valsaran, rosuvastatin	Up to 144 hours post-dose

Trial Locations

Locations (1)

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