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Completed

NCT Number: NCT02686294

Repeated Dosing Clinical Trial of HL151

The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine 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

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Korea Univertisy Anam Hospital

Seoul, 136-705, 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 19-45
  • Body weight ≥ 50kg, BMI 18~29 kg/m2
  • 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 acute disease within 28 days prior to study medication dosing
  • Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
  • Subject with clinically significant chronic disease
  • Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
  • Use of any prescription medication within 14 days prior to study medication dosing
  • Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
  • Subject with clinically significant allergic disease
  • Subject with known for hypersensitivity reaction to bepotastine
  • Subject with any of the following conditions in laboratory test
  • AST/ALT > UNL (upper normal limit) x 2
  • Total bilirubin > UNL x 2
  • Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
  • SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg
  • QTc>440msec on ECG
  • Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
  • Immunological incompetence, immune deficiency or taking immunosuppressants
  • Subject who cannot take standard meal
  • Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
  • Subject with blood transfusion within 30days prior to study medication dosing
  • Participation in any clinical investigation within 90days prior to study medication dosing
  • Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
  • 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
  • Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
  • Subject who are not using adequate means of contraception
  • Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
  • Subject with history of drug abuse or drug addiction

Treatment and study plan

HL151

Drug

Test drug : HL151. 1T, once a day oral administration, for 4 days

TALION tab.

Drug

Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days

Primary outcomes

  1. Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)

    Time frame: 24 hours after 4 days' repeated dosing

  2. Maximum the plasma concentration during a dosing interval(Cmax,ss)

    Time frame: 24 hours after 4 days' repeated dosing

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge)

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 19, 2016
Registry last updated
Aug 17, 2018

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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