Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

NCT ID: NCT02955498

Last Updated: 2016-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

R-T

First period: administration of reference drug, Second period: administration of test drug

Group Type: EXPERIMENTAL

Sevikar tab. 10/40mg

Intervention Type: DRUG

Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state

Lodivikar tab. 5/40mg

Intervention Type: DRUG

Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

T-R

First period: administration of test drug, Second period: administration of reference drug

Group Type: EXPERIMENTAL

Sevikar tab. 10/40mg

Intervention Type: DRUG

Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state

Lodivikar tab. 5/40mg

Intervention Type: DRUG

Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

Interventions

Sevikar tab. 10/40mg

Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state

Intervention Type: DRUG

Lodivikar tab. 5/40mg

Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male in the age of 20-45
• Body weight ≥ 55kg, IBW ± 20%
• Subject who sign on an informed consent form willingly

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 known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
• Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period
• Subject with known for history of disease or gastric surgery which affect on the absorption,
• Subject with any of the following conditions in laboratory test

• AST or ALT > UNL (upper normal limit) x 1.5
• Total bilirubin > UNL x 1.5
• Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
• Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
• Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
• Participation in any clinical investigation within 60days prior to study medication dosing
• Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
• Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing
• Subject with mental illness or drug addiction
• Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing
• Subject 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metrohospital

Anyang, Kyung Gi, South Korea

Countries

South Korea

Other Identifiers

HL-LVK-101

Identifier Type: -

Identifier Source: org_study_id