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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination

• Registration Number: NCT02182531
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08
• Primary Completion: 1999-10
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Epinastine	Pseudoephedrine	-
Pseudoephedrine	Epinastine	-
Pseudoephedrine	Pseudoephedrine	-
Epinastine and Pseudoephedrine combination	Epinastine + Pseudoephedrine combination	-
Pseudoephedrine	Epinastine + Pseudoephedrine combination	-
Epinastine	Epinastine + Pseudoephedrine combination	-
Epinastine and Pseudoephedrine combination	Pseudoephedrine	-
Epinastine and Pseudoephedrine combination	Epinastine	-
Epinastine	Epinastine	-

Primary Outcome Measures

Name	Time	Method
Index of the absorption rate Cpmax/AUCt (Peak plasma concentration/Area under the curve from zero to 24 hours)	Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Area under the curve (AUC) of the analyte in plasma	Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
T1/2 (Drug half-life)	Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Number of withdrawals and discontinuations due to safety reasons	up to 15 days
Peak plasma concentration (Cpmax)	Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Tmax (Time to reach Cpmax)	Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Number of patients with adverse events	up to 15 days
Number of patients with clinically significant changes in vital signs	Baseline, day 1, 8, 15