Bioequivalence Study of CJ-30060 in Healthy Volunteers

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg; period 2: receive CJ-30060 5/160/10mg	Drug: Exforge® tab 5/160mg, Crestor® tab 10mg; co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg; Drug: CJ-30060 5/160/10mg; Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg
Experimental: Sequence 2; period 1: receive CJ-30060 5/160/10mg; period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg	Drug: Exforge® tab 5/160mg, Crestor® tab 10mg; co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg; Drug: CJ-30060 5/160/10mg; Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of amlodipine	Up to 144 hours post-dose
AUClast of amlodipine	Up to 144 hours post-dose
Cmax of valsartan	Up to 48 hours post-dose
Cmax of rosuvastatin	Up to 72 hours post-dose
AUClast of valsartan	Up to 48 hours post-dose
AUClast of rosuvastatin	Up to 72 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Ji Young Park, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): December 14, 2018
• Study Completion (Anticipated): December 14, 2018

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: CJ_EXR_104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No