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

COMPLETEDPHASE1

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

NCT01652339•Hanlim Pharm. Co., Ltd.

View on ClinicalTrials.gov

Summary

To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects * PK parameter evaluation * Safety profile evaluation

Eligibility

Age

20 - 40 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Years 20-45
•Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
•volunteer

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 28days prior to study medication dosing
•Subject with known for 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 dosing
•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)
+10 more criteria

Locations (1)

Inje University Busan Paik Hospital

Busan, South Korea

Key Dates

Start Date

July 1, 2012

Primary Completion Date

August 1, 2012

Completion Date

December 1, 2012

Last Updated

March 26, 2013

Enrollment

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

Exforge tab. 10/160mg

DRUG

Lodivixx tab. 5/160mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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