Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000489

Enrollment

Registered

2012-07-23

Start date

2012-07-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Reference drug : Exforge tab. 10/160mg(amlodipine 10mg + valsartan 160mg), 1 tab., single oral administration Test drug : Lodivixx tab. 5/160mg(S-amlodipine 5mg + valsartan 160mg), 1 tab., sing

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Years 20-45 2) Body weight=50kg and 18=BMI=29kg/m2 3) volunteer

Exclusion criteria

Exclusion criteria: 1) Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2) Subject with symptoms of acute disease within 28days prior to study medication dosing 3) Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug 4) Subject with clinically significant active chronic disease 5) 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. reanl failure with Creatinine clearance five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day) 17) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice 18) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing 19) Contined serum potassium concentration abnormal status (on baseline visit, 5.5mEq/L) 20) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to requst or instruction by investigator

Design outcomes

Primary

Measure	Time frame
pharmacokinetic evaluation(Cmax, AUCt)	—

Secondary

Measure	Time frame
Safety and Tolerability evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactMyeong Hwa Kim

Inje University Busan Paik Hospital

Outcome results