Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639493
• Other study ID #: CJ_EXR_103
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2018
• Est. completion date: May 17, 2018

Study information

• Verified date: August 2018
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg 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® 10/160mg, Crestor® 20mg in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 17, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy males aged 20 to 45 years at screening

• BMI: 18 ~ 29.9kg/m^2

• 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 28 days 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) x 2

• Total bilirubin > UNL x 1.5

• CrCL < 50mL/min

• CPK > UNL x 2.5

• Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)

• Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• Exforge® tab 10/160mg, Crestor® tab 20mg
Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
• CJ-30060 10/160/20mg
Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg

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	Cmax of amlodipine		Up to 144 hours post-dose
Primary	Cmax of valsartan		Up to 144 hours post-dose
Primary	Cmax of rosuvastatin		Up to 144 hours post-dose
Primary	AUClast of amlodipine		Up to 144 hours post-dose
Primary	AUClast of valsartan		Up to 144 hours post-dose
Primary	AUClast of rosuvastatin		Up to 144 hours post-dose
Secondary	AUCinf of amlodipine, valsaran, rosuvastatin		Up to 144 hours post-dose