Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01735890

Enrollment

Registered

2012-11-28

Start date

2012-09-30

Completion date

2012-11-30

Last updated

2013-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Pharmacokinetics

Brief summary

The objectives of this study are: * To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers * To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Interventions

DRUGCJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Years 20-45 * 18 ≤ BMI \< 27kg/m² * volunteer

Exclusion criteria

* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing * Subject with symptoms of acute disease within 28days prior to study medication dosing * Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines * Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing * Subject with known for hypersensitivity reaction to amlodipine and valsartan * Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1.5 ii. Total bilirubin \> Upper normal limit × 1.5 iii. eGFR\< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, \< 3.5mEq/L or \> 5.5mEq/L) * Positive test results for HBs Ab, HCV Ab, Syphilis regain test * Drug abuse or continued excessive use of caffeine (caffeine \> five cups/day), severe heavy smoker (cigarette \> 10 cigarettes per day) and alcohol(alcohol\>30g/day) * Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice * Clinically significant hypotension(SBP \< 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP \< 65mmHg) when screening period * Participation in any clinical investigation within 60days prior to study medication dosing * Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing * Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

Design outcomes

Primary

Measure	Time frame
pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast))	Up to 144 hours

Secondary

Measure	Time frame
AUCinf, Tmax, T1/2, CL/F	up to 144 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026