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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009474
• Other study ID #: CJ_EXR_102
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2015
• Last updated: January 3, 2017
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: January 2017
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No
Secondary	Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No
Secondary	Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No
Secondary	Half life (t1/2) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No
Secondary	Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No
Secondary	Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin		Up to 144 hours post-dose	No