Clinical trial NCT02260063: Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers
Official title: A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) of plasma concentration (CP)
timeFrame: Up to 24 hours after drug administration
measure: Absorption rate Cpmax/AUC
timeFrame: Up to 24 hours after drug administration
Secondary outcomes:
measure: Peak plasma concentration (Cpmax)
timeFrame: Up to 24 hours after drug administration
measure: Time to peak (Tmax)
timeFrame: Up to 24 hours after drug administration
measure: Drug half - life (T1/2)
timeFrame: Up to 24 hours after drug administration
measure: Number of participants with adverse events
timeFrame: Up to 24 hours after last drug administration
measure: Number of participants withdrawn or discontinued due to safety reasons
timeFrame: Up to 24 hours after last drug administration
measure: Number of participants with abnormal findings in physical examination
timeFrame: Up to 24 hours after last drug administration
measure: Number of participants with clinically significant findings in vital signs
timeFrame: Up to 24 hours after last drug administration
Other outcomes:
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