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

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: Sevikar tab. 10/40mg; Drug: Lodivikar tab. 5/40mg

• Registration Number: NCT02955498
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-11
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Study First Posted: 2016-11-04
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
R-T	Sevikar tab. 10/40mg	First period: administration of reference drug, Second period: administration of test drug
R-T	Lodivikar tab. 5/40mg	First period: administration of reference drug, Second period: administration of test drug
T-R	Lodivikar tab. 5/40mg	First period: administration of test drug, Second period: administration of reference drug
T-R	Sevikar tab. 10/40mg	First period: administration of test drug, Second period: administration of reference drug

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
Peak Plasma Concentration (Cmax)	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From study medication dosing day to follow-up period for maximum 7 days from the second period discharge

Trial Locations

Locations (1)

Metrohospital; 🇰🇷 Anyang, Kyung Gi, Korea, Republic of