Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Exforge® tab 10/160mg, Crestor® tab 20mg; Drug: CJ-30060 10/160/20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03639493

CJ_EXR_103

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Sequence 1

Experimental group

Description:

* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg * Period 2: receive CJ-30060 10/160/20mg

Treatment:

Drug: CJ-30060 10/160/20mg

Drug: Exforge® tab 10/160mg, Crestor® tab 20mg

Sequence 2

Experimental group

Description:

* Period 1: receive CJ-30060 10/160/20mg * Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg

Treatment:

Drug: CJ-30060 10/160/20mg

Drug: Exforge® tab 10/160mg, Crestor® tab 20mg