Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Brief Summary

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Study to compare the bioavailable fraction of epinastine and pseudoephedrine when administered as a fixed dose combination in tablet form (new pharmaceutical formulation), with that obtained with each of these drugs when administered separately to healthy volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epinastine and Pseudoephedrine combination

Group Type EXPERIMENTAL

Epinastine

Intervention Type DRUG

Pseudoephedrine

Intervention Type DRUG

Epinastine + Pseudoephedrine combination

Intervention Type DRUG

Epinastine

Group Type ACTIVE_COMPARATOR

Epinastine

Intervention Type DRUG

Pseudoephedrine

Intervention Type DRUG

Epinastine + Pseudoephedrine combination

Intervention Type DRUG

Pseudoephedrine

Group Type ACTIVE_COMPARATOR

Epinastine

Intervention Type DRUG

Pseudoephedrine

Intervention Type DRUG

Epinastine + Pseudoephedrine combination

Intervention Type DRUG

Interventions

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Epinastine

Intervention Type DRUG

Pseudoephedrine

Intervention Type DRUG

Epinastine + Pseudoephedrine combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers of both sexes aged between 21 and 45 years
* Non-smoking volunteers
* Volunteers willing to abstain from alcohol
* The volunteers will have to have suspended any drug treatment at least two weeks prior to the start of the study
* Informed consent in writing, signed in time for the start of the study

Exclusion Criteria

* Women who are pregnant, breast-feeding or receiving hormonal contraceptives
* Volunteers who require drug treatment of any kind of a chronic nature or due to a known addiction
* Volunteers who have taken part in another clinical trial during the preceding four weeks
* Volunteers who have to begin treatment incompatible with this one during the period of the present study (systemic anaesthetics by inhalation, antihypertensives or diuretics used as antihypertensives, beta-adrenergic blockers, CNS (central nervous system) stimulants, digitalis, glycosides, levodopa, monoamine oxidase inhibitors, nitrates, rauwolfia alkaloids, thyroid hormone sympathomimetics)
* Volunteers who do not observe the fasting stipulated in the study or who do not satisfy its requirements with respect to avoiding the ingestion of coffee, tea, cola drinks, etc. during the 24 hours prior to the study
* Volunteers with a history of hepatic or renal disease and disorders of psychiatric origin
* A history of allergy or intolerance with respect to epinastine or pseudoephedrine
* Volunteers who are intolerant of other sympathomimetics (e.g. salbutamol, amphetamine, ephedrine, etc.)
* Non-cooperative volunteers
* Previous participation in this study
* Histories of cardiovascular disease, ischaemic heart disease, hypertension, diabetes mellitus, glaucoma, hyperthyroidism, prostatic hypertrophy

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes