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

Hanlim Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Lodivikar tab. 5/40mg; Drug: Sevikar tab. 10/40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02955498

HL-LVK-101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

R-T

Experimental group

Description:

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

Treatment:

Drug: Lodivikar tab. 5/40mg

Drug: Sevikar tab. 10/40mg

T-R

Experimental group

Description:

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

Treatment:

Drug: Lodivikar tab. 5/40mg

Drug: Sevikar tab. 10/40mg