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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02182531
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Epinastine Drug: Pseudoephedrine Drug: Epinastine + Pseudoephedrine combination Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 1999
Actual Primary Completion Date : October 1999

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Area under the curve (AUC) of the analyte in plasma [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  2. Tmax (Time to reach Cpmax) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  3. T1/2 (Drug half-life) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  4. Number of patients with adverse events [ Time Frame: up to 15 days ]
  5. Number of withdrawals and discontinuations due to safety reasons [ Time Frame: up to 15 days ]
  6. Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, day 1, 8, 15 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
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
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Responsible Party: Boehringer Ingelheim Identifier: NCT02182531    
Other Study ID Numbers: 262.255
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents