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

Healthy Male Subjects Clinical Trial

Official title:

A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955498
• Other study ID #: HL-LVK-101
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2016
• Last updated: November 2, 2016
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• Sevikar tab. 10/40mg
Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state
• Lodivikar tab. 5/40mg
Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

Locations

Country	Name	City	State
Korea, Republic of	Metrohospital	Anyang	Kyung Gi

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Number of participants with adverse events		From study medication dosing day to follow-up period for maximum 7 days from the second period discharge	Yes