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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182531

262.255

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Epinastine and Pseudoephedrine combination

Experimental group

Treatment:

Drug: Pseudoephedrine

Drug: Epinastine + Pseudoephedrine combination

Drug: Epinastine

Epinastine

Active Comparator group

Treatment:

Drug: Pseudoephedrine

Drug: Epinastine + Pseudoephedrine combination

Drug: Epinastine

Pseudoephedrine

Active Comparator group

Treatment:

Drug: Pseudoephedrine

Drug: Epinastine + Pseudoephedrine combination

Drug: Epinastine