Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

NCT02260063 | Completed Phase 1

• 1 other identifier: 262.252
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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• Number of participants withdrawn or discontinued due to safety reasons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

Study Arms (2)

Epinastine syrup

EXPERIMENTAL

Drug: Epinastine syrup

Epinastine tablets

ACTIVE COMPARATOR

Drug: Epinastine tablets

Interventions

Epinastine syrup DRUG

Epinastine syrup

Epinastine tablets DRUG

Epinastine tablets

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

epinastine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 9, 2014
• Study Start: November 1, 1998
• Primary Completion: January 1, 1999
• Last Updated: October 9, 2014

Record last verified: 2014-10