Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Epinastine tablets; Drug: Epinastine syrup

• Registration Number: NCT02260063
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Primary Completion: 1999-01
• Status Verified: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• male and female, non-smoker and non-alcohol user, healthy volunteers, of 21 - 45 years of age. To be eligible, women must not be pregnant or lactating and they must not be taking hormone contraceptives
• Volunteers must not have a history of liver or renal disease or a history of psychiatric disorder. Volunteers will be submitted to the biochemical tests listed below, the results of which must be within expected normal values: complete blood count, erythro-sedimentation rate, GOT (glutamate oxalacetate transaminase) GPT (glutamate pyruvate transaminase), blood creatinine, glycemia, uremia, blood cholesterol, pregnancy test. HIV test (with prior written consent), serum tests for Chagas disease, hepatic b and syphilis, complete urinalysis, ECG (electrocardiogram) and chest x-ray
• Volunteers must have discontinued all pharmacological treatment at least two weeks before entering this trial
• informed written consent, signed prior to the start of this trial

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Exclusion Criteria

• Volunteers requiring any kind of pharmacological treatment or having some known addiction
• Volunteers having participated in any other clinical trial during the four preceding weeks
• Volunteers who must start a treatment incompatible with this trial during its course
• Volunteers who do not comply with the fasting requirements established in the trial or who do not comply with trial requirements such as avoiding intake of coffee, tea, cola soft drinks, etc. for 24 hours prior to the start of the trial
• History of allergy or intolerance to Epinastine
• Uncooperative volunteers
• Previous participation in this trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Epinastine tablets	Epinastine tablets	-
Epinastine syrup	Epinastine syrup	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of plasma concentration (CP)	Up to 24 hours after drug administration
Absorption rate Cpmax/AUC	Up to 24 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 24 hours after last drug administration
Number of participants with abnormal findings in physical examination	Up to 24 hours after last drug administration
Time to peak (Tmax)	Up to 24 hours after drug administration
Peak plasma concentration (Cpmax)	Up to 24 hours after drug administration
Drug half - life (T1/2)	Up to 24 hours after drug administration
Number of participants withdrawn or discontinued due to safety reasons	Up to 24 hours after last drug administration
Number of participants with clinically significant findings in vital signs	Up to 24 hours after last drug administration