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

Study of the Pharmacokinetic Interactions and Relative Bioavailability of Epinastine and Pseudoephedrine in Healthy Volunteers, Comparing Tablets Containing the Fixed Combination of the Two Substances With Tablets Containing Each of the Two Substances Separately

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epinastine and Pseudoephedrine combination	Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination
Active Comparator: Epinastine	Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination
Active Comparator: Pseudoephedrine	Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
T1/2 (Drug half-life)	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 withdrawals and discontinuations due to safety reasons	up to 15 days
Number of patients with clinically significant changes in vital signs	Baseline, day 1, 8, 15

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): October 1, 1999

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine; Epinastine
• Other Study ID Numbers: 262.255