Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

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

Official Title
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A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets

Conditions
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Healthy

Intervention / Treatment
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* Drug: Epinastine syrup
* Drug: Epinastine tablets


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epinastine syrup<br> | Drug: Epinastine syrup<br> <br> |
| Active Comparator: Epinastine tablets<br> | Drug: Epinastine tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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