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

Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects

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 Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemias
• Intervention / Treatment: Drug: Exforge tab 5/160mg, Crestor tab 10mg; Drug: CJ-30060

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 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: Male

Description

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 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: CJ-30060; Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg	Drug: Exforge tab 5/160mg, Crestor tab 10mg; Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
Active Comparator: Exforge tab 5/160mg, Crestor tab 10mg; Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg	Drug: CJ-30060; Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin	Up to 144 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) 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
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
Apparent volume of distribution (Vd/F) 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: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

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; Rosuvastatin Calcium; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: CJ_EXR_102

Plan for Individual participant data (IPD)

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