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

NCT02955498 | Completed Phase 1

• 1 other identifier: HL-LVK-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with adverse events

  From study medication dosing day to follow-up period for maximum 7 days from the second period discharge

Study Arms (2)

R-T

EXPERIMENTAL

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

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

T-R

EXPERIMENTAL

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

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

Interventions

Sevikar tab. 10/40mg DRUG

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

R-T; T-R

Lodivikar tab. 5/40mg DRUG

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

R-T; T-R

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Metrohospital

Anyang, Kyung Gi, 430-720, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 4, 2016
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

KR (1)