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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Epinastine (Drug); Pseudoephedrine (Drug); Epinastine + Pseudoephedrine combination (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the curve (AUC) of the analyte in plasma

Index of the absorption rate Cpmax/AUCt (Peak plasma concentration/Area under the curve from zero to 24 hours)

Secondary outcome:

Peak plasma concentration (Cpmax)

Tmax (Time to reach Cpmax)

T1/2 (Drug half-life)

Number of patients with adverse events

Number of withdrawals and discontinuations due to safety reasons

Number of patients with clinically significant changes in vital signs


Minimum age: 21 Years. Maximum age: 45 Years. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

Additional Information

Starting date: August 1999
Last updated: July 11, 2014

Page last updated: August 20, 2015

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