Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Exforge® 5/160mg & Lipitor® 20mg; Drug: CJ-30061

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657472

CJ_EXA_103

Details and patient eligibility

About

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Enrollment: 42 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male aged 19 to 55 years at the time of signing informed consent form.
• Subject with BMI from 19kg/m^2 to 27kg/m^2
• Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion criteria

• Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.

• Subject who fall under the criteria below in laboratory test.

  • AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
  • CPK > UNL x 2.5
  • CrCL < 60mL/min

• Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Sequence 1(RTR)

Experimental group

Treatment:

Drug: Exforge® 5/160mg & Lipitor® 20mg

Drug: CJ-30061

Sequence 2(RRT)

Experimental group

Treatment:

Drug: Exforge® 5/160mg & Lipitor® 20mg

Drug: CJ-30061

Sequence 3(TRR)

Experimental group

Treatment:

Drug: Exforge® 5/160mg & Lipitor® 20mg

Drug: CJ-30061