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Completed

NCT Number: NCT01925313

A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers

Study objectives

* To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers. * To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei university severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male volunteers in the age between 20 and 45 years old
  • BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
  • Subject with no history of any significant chronic disease
  • Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion criteria

  • History of clinically significant allergies, including Bepotastine.
  • History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
  • History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
  • Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
  • Clinical laboratory test values are outside the accepted normal range
  • AST or ALT >1.25 times to normal range
  • Total bilirubin >1.5 times to normal range
  • Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
  • Clinically significant vital sign
  • SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
  • DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
  • History of drug abuse or positive urine screen for drugs
  • History of caffeine, alcohol, smoking abuse
  • caffeine > 5 cups/day
  • alcohol > 210g/week
  • smoking > 10 cigarettes/day
  • Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
  • Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
  • Participated in a previous clinical trial within 60 days prior to dosing
  • Donated blood within 60 days prior to dosing
  • Subjects considered as unsuitable based on medical judgement by investigators

Treatment and study plan

CJ-30044

Drug

20.51mg a day,PO,QD

TALION TAB. 10mg

Drug

10mg a day,PO,BID

Primary outcomes

  1. AUClast and Peak plasma concentration (Cmax) of Bepotastine

    Time frame: Blood sampling up to 36hs post dose.

Secondary outcomes

  1. AUCinf, Tmax, T1/2 of Bepotastine

    Time frame: Blood sampleing up to 36hrs post dose

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2013
Registry last updated
Aug 19, 2013

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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