Status:
COMPLETED
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
Hanlim Pharm. Co., Ltd.
Conditions:
Allergic Rhinitis
Urticaria
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01897428
Start Date
April 1 2011
End Date
August 1 2011
Last Update
July 12 2013
Active Locations (1)
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1
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital
Seoul, Seoul, South Korea, 136-705