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OpenTrials
Completed

NCT Number: NCT01897428

PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pruritus Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Urticaria

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dept. of Clinical Pharmacology & Toxicology, 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

  • subjects aged between 20 and 45 years
  • Body weight > 50 kg (in case of female > 45 kg) with BMI between 18 and 29 kg/m2
  • Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion criteria

  • subjects with acute conditions.
  • presence of history affecting ADME
  • Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
  • Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
  • Any other acute or chronic disease
  • A history of hypersensitivity to bepotastine
  • A history of alcohol or drug abuse
  • Participation in another clinical trial within 2 months
  • smoked >10 cigarettes daily
  • consumption over 5 glasses daily of beverages containing xanthine derivatives
  • use of any medication having the potential to affect the study results within 10 days before the start of the study.
  • medication of the inhibitors or inducers of DME including barbiturates within 1 month
  • one of abnormal lab findings as like
  • c. AST/ALT > UNL (upper normal limit) x 1.5
  • Total bilirubin > UNL x 1.5

Treatment and study plan

Test-Bepotastine salicylate 9.64 mg

Drug

Other names: Berion, Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Reference-bepotastine besilate 10 mg

Drug

Other names: Tarion, Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea

Primary outcomes

  1. bepotastine pharmacokinetics: peak plasma concentrations (Cmax)

    Time frame: 24 hr

  2. Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)

    Time frame: 24 hr

  3. Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)

    Time frame: 24 hr

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Hanlim Pharm. Co., Ltd.

Registry information

Official study title

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2013
Registry last updated
Jul 12, 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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