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Completed

NCT Number: NCT02955498

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Metrohospital

Anyang, Kyung Gi, 430-720, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevikar tab. 10/40mg

Drug

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

Lodivikar tab. 5/40mg

Drug

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

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)

  2. Peak Plasma Concentration (Cmax)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2016
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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