Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Epinastine syrup; Drug: Epinastine tablets

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epinastine syrup	Drug: Epinastine syrup
Active Comparator: Epinastine tablets	Drug: Epinastine tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Primary Completion (Actual): January 1, 1999

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Epinastine
• Other Study ID Numbers: 262.252