Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Epinastine syrup; Drug: Epinastine tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260063

262.252

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Epinastine syrup

Experimental group

Treatment:

Drug: Epinastine syrup

Epinastine tablets

Active Comparator group

Treatment:

Drug: Epinastine tablets