Bioequivalence Study of CJ-30060 in Healthy Volunteers

Phase 1

• Conditions: Healthy Subjects
• Interventions: Drug: Exforge® tab 5/160mg, Crestor® tab 10mg; Drug: CJ-30060 5/160/10mg

• Registration Number: NCT03757390
• 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 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 volunteers.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-09
• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-11-25
• Last Update Submitted: 2018-11-25
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Exforge® tab 5/160mg, Crestor® tab 10mg	* period 1: receive CJ-30060 5/160/10mg * period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
Sequence 1	Exforge® tab 5/160mg, Crestor® tab 10mg	* period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg * period 2: receive CJ-30060 5/160/10mg
Sequence 1	CJ-30060 5/160/10mg	* period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg * period 2: receive CJ-30060 5/160/10mg
Sequence 2	CJ-30060 5/160/10mg	* period 1: receive CJ-30060 5/160/10mg * period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg

Primary Outcome Measures

Name	Time	Method
Cmax of amlodipine	Up to 144 hours post-dose
Cmax of rosuvastatin	Up to 72 hours post-dose
AUClast of valsartan	Up to 48 hours post-dose
Cmax of valsartan	Up to 48 hours post-dose
AUClast of amlodipine	Up to 144 hours post-dose
AUClast of rosuvastatin	Up to 72 hours post-dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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