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

NCT01735890 | Completed Phase 1

• 1 other identifier: CJ_AMV_102
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Keywords

Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast))

  Up to 144 hours

Secondary Outcomes (1)

• AUCinf, Tmax, T1/2, CL/F

  up to 144 hours

Study Arms (2)

CJ Amlodipine/Valsartan 10/160mg

EXPERIMENTAL

Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

Novartis Exforge 10/160mg

ACTIVE COMPARATOR

Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

Interventions

CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg DRUG

single dose

CJ Amlodipine/Valsartan 10/160mg; Novartis Exforge 10/160mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Related Publications (1)

• 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.

  PMID: 25034618 DERIVED

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: November 28, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 13, 2013

Record last verified: 2012-11