Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

Healthy Male Subjects Clinical Trial

Official title:

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648333
• Other study ID #: HL-LDV-103
• Status: Completed
• Phase: Phase 1
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2018
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults

Description:

The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Years 20-45

• Body weight = 50kg and 18 = BMI = 29kg/m2

• Volunteer for the study and sign to ICF

Exclusion Criteria:

• Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease

• Subject with symptoms of acute disease within 28 days prior to study medication

• Subject with history which affect on the absorption, distribution, metabolism or excretion of drug

• Subject with clinically significant active chronic disease

• 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. renal failure with Creatinine clearance < 50mL/min

• Clinically significant hypotension when screening period (SBP < 100mmHg, DBP < 60mmHg)

• Positive test results for HBs Ab, HCV Ab, Syphilis regain test

• Use of any prescription medication within 14 days prior to study medication

• Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing

• Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)

• Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives

• Subject who is not able to taking the institutional standard meal

• Subjects with whole blood donation within 60 days, component blood donation within 20 days

• Subjects receiving blood transfusion within 30 days prior to study medication dosing

• Participation in any clinical investigation within 60 days prior to study medication dosing

• Continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol (alcohol>30 g/day)

• Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice

• Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28 days prior to study medication dosing

• Continued serum potassium concentration abnormal status (on baseline visit, < 3.5 mEq/L or > 5.5 mEq/L)

• 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

• Severe renal insufficient subjects (creatinine clearance : less than 10 mL/min)

• Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient

• Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60 mL/min/1.73m2)

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• Exforge tab. 10/160mg

• Lodivixx tab. 5/160mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum concentration)		0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
Primary	AUC(area under curve)		0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
Secondary	Number of participants with adverse events		0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour