Bioequivalence Study of CJ-30060 in Healthy Volunteers

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Exforge® tab 5/160mg, Crestor® tab 10mg; Drug: CJ-30060 5/160/10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03757390

CJ_EXR_104

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers aged 20 to 45 years at screening
• BMI: 18~29.9kg/㎡
• 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 28days 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) × 2
  • Total bilirubin > UNL × 1.5
  • CrCL < 50mL/min
  • CPK > UNL × 2.5

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

• Subjects with any positive reaction in HBsAg, 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 5/160mg, Crestor® tab 10mg * period 2: receive CJ-30060 5/160/10mg

Treatment:

Drug: CJ-30060 5/160/10mg

Drug: Exforge® tab 5/160mg, Crestor® tab 10mg

Sequence 2

Experimental group

Description:

* period 1: receive CJ-30060 5/160/10mg * period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg

Treatment:

Drug: CJ-30060 5/160/10mg

Drug: Exforge® tab 5/160mg, Crestor® tab 10mg