Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009474
Other study ID # CJ_EXR_102
Secondary ID
Status Completed
Phase Phase 1
First received March 11, 2015
Last updated January 3, 2017
Start date February 2015
Est. completion date April 2015

Study information

Verified date January 2017
Source CJ HealthCare Corporation
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy male aged 20 to 45 years at the screening

- Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)

- Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria:

- Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.

- Subject who have symptoms, result from acute disease within 28days before first administration.

- Subject who have chronic persisting disease with clinical significance.

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

- AST/ALT > UNL (upper normal limit) x 2

- Total bilirubin > UNL x 1.5

- In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault

- CPK > UNL x 2.5

- Subject who with low blood pressure with clinical significance at screening test.

(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)

- Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CJ-30060
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
Exforge tab 5/160mg, Crestor tab 10mg
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg

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 Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
Secondary Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
Secondary Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
Secondary Half life (t1/2) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
Secondary Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
Secondary Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin Up to 144 hours post-dose No
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A
Completed NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A