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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CJ Cheiljedang Corporation

ClinicalTrials.gov Identifier:

NCT01494727

First received: December 15, 2011

Last updated: April 29, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 15, 2011
Last Updated Date	April 29, 2012
Start Date ^ICMJE	February 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01494727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
Official Title ^ICMJE	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
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: CJ Amlodipine/Valsartan 10/160mg single dose Drug: Novartis Exforge 10/160mg single dose
Study Arm (s)	Experimental: CJ Amlodipine/Valsartan 10/160mg Intervention: Drug: CJ Amlodipine/Valsartan 10/160mg Active Comparator: Novartis Exforge 10/160mg Intervention: Drug: Novartis Exforge 10/160mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	48
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male volunteers in the age between 20 and 45 years old Body Mass Index (BMI) in the range of 19 to 27 kg/m2 Exclusion Criteria: History of allergy or sensitivity to any drug, including amlodipine or valsartan History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg) Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg) Clinical laboratory test values are outside the accepted normal range Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range Total bilirubin > 1.25 times to normal range Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)
Gender	Male
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01494727
Other Study ID Numbers ^ICMJE	CJ_AMV_101
Has Data Monitoring Committee	No
Responsible Party	CJ Cheiljedang Corporation
Study Sponsor ^ICMJE	CJ Cheiljedang Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CJ Cheiljedang Corporation
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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