Clinical trial NCT01735890: Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast))
timeFrame: Up to 144 hours
Secondary outcomes:
measure: AUCinf, Tmax, T1/2, CL/F
timeFrame: up to 144 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Nam JH, Oh M, Kim HJ, Han SK, Kim EJ, Song GS, Kim EY, Shin JG, Ghim JL, Kim HS. Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Jan;53(1):66-74. doi: 10.5414/CP202045.