Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

Hypertension Clinical Trial

Official title:

An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657472
• Other study ID #: CJ_EXA_103
• Status: Completed
• Phase: Phase 1
• Start date: September 19, 2016
• Est. completion date: November 9, 2016

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-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 9, 2016
• Est. primary completion date: October 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Drug:
• CJ-30061
Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
• Exforge® 5/160mg & Lipitor® 20mg
Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	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 72 hours
Primary	Cmax of valsartan		Up to 72 hours
Primary	Cmax of atorvastatin		Up to 72 hours
Primary	AUCt of amlodipine		Up to 72 hours
Primary	AUCt of valsartan		Up to 72 hours
Primary	AUCt of atorvastatin		Up to 72 hours
Secondary	tmax of amlodipine		Up to 72 hours
Secondary	tmax of valsartan		Up to 72 hours
Secondary	tmax of atorvastatin		Up to 72 hours
Secondary	t1/2 of atorvastatin		Up to 72 hours
Secondary	t1/2 of amlodipine		Up to 72 hours
Secondary	t1/2 of valsartan		Up to 72 hours
Secondary	AUCinf of amlodipine		Up to 72 hours
Secondary	AUCinf of valsartan		Up to 72 hours
Secondary	AUCinf of atorvastatin		Up to 72 hours
Secondary	AUCt of 2-OH atorvastatin		Up to 72 hours
Secondary	Cmax of 2-OH atorvastatin		Up to 72 hours
Secondary	tmax of 2-OH atorvastatin		Up to 72 hours
Secondary	t1/2 of 2-OH atorvastatin		Up to 72 hours
Secondary	AUCinf of 2-OH atorvastatin		Up to 72 hours