Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Drug: CJ-30061; Drug: Exforge® 5/160mg & Lipitor® 20mg

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male aged 19 to 55 years at the time of signing informed consent form.
• Subject with BMI from 19kg/m^2 to 27kg/m^2
• Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion Criteria:

• Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.

• Subject who fall under the criteria below in laboratory test.

  • AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
  • CPK > UNL x 2.5
  • CrCL < 60mL/min
• Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1(RTR)	Drug: CJ-30061; Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg); Drug: Exforge® 5/160mg & Lipitor® 20mg; Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Experimental: Sequence 2(RRT)	Drug: CJ-30061; Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg); Drug: Exforge® 5/160mg & Lipitor® 20mg; Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Experimental: Sequence 3(TRR)	Drug: CJ-30061; Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg); Drug: Exforge® 5/160mg & Lipitor® 20mg; Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of amlodipine	Up to 72 hours
Cmax of valsartan	Up to 72 hours
Cmax of atorvastatin	Up to 72 hours
AUCt of amlodipine	Up to 72 hours
AUCt of valsartan	Up to 72 hours
AUCt of atorvastatin	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax of amlodipine	Up to 72 hours
tmax of valsartan	Up to 72 hours
tmax of atorvastatin	Up to 72 hours
t1/2 of atorvastatin	Up to 72 hours
t1/2 of amlodipine	Up to 72 hours
t1/2 of valsartan	Up to 72 hours
AUCinf of amlodipine	Up to 72 hours
AUCinf of valsartan	Up to 72 hours
AUCinf of atorvastatin	Up to 72 hours
AUCt of 2-OH atorvastatin	Up to 72 hours
Cmax of 2-OH atorvastatin	Up to 72 hours
tmax of 2-OH atorvastatin	Up to 72 hours
t1/2 of 2-OH atorvastatin	Up to 72 hours
AUCinf of 2-OH atorvastatin	Up to 72 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: JaeWook Ko, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): October 29, 2016
• Study Completion (Actual): November 9, 2016

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: CJ_EXA_103

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