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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02182531
Collaborator
(none)
25
Enrollment
3
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Oct 1, 1999

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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

  1. Peak plasma concentration (Cpmax) [Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose]

  2. Tmax (Time to reach Cpmax) [Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose]

  3. T1/2 (Drug half-life) [Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose]

  4. Number of patients with adverse events [up to 15 days]

  5. Number of withdrawals and discontinuations due to safety reasons [up to 15 days]

  6. Number of patients with clinically significant changes in vital signs [Baseline, day 1, 8, 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02182531
Other Study ID Numbers:
  • 262.255
First Posted:
Jul 8, 2014
Last Update Posted:
Jul 14, 2014
Last Verified:
Jul 1, 2014
Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Epinastine

Study Results

No Results Posted as of Jul 14, 2014