Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02182531
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE August 1999
Actual Primary Completion Date October 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
  • Peak plasma concentration (Cpmax) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  • Tmax (Time to reach Cpmax) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  • T1/2 (Drug half-life) [ Time Frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose ]
  • Number of patients with adverse events [ Time Frame: up to 15 days ]
  • Number of withdrawals and discontinuations due to safety reasons [ Time Frame: up to 15 days ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, day 1, 8, 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Epinastine
  • Drug: Pseudoephedrine
  • Drug: Epinastine + Pseudoephedrine combination
Study Arms  ICMJE
  • Experimental: Epinastine and Pseudoephedrine combination
    Interventions:
    • Drug: Epinastine
    • Drug: Pseudoephedrine
    • Drug: Epinastine + Pseudoephedrine combination
  • Active Comparator: Epinastine
    Interventions:
    • Drug: Epinastine
    • Drug: Pseudoephedrine
    • Drug: Epinastine + Pseudoephedrine combination
  • Active Comparator: Pseudoephedrine
    Interventions:
    • Drug: Epinastine
    • Drug: Pseudoephedrine
    • Drug: Epinastine + Pseudoephedrine combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2014)
25
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182531
Other Study ID Numbers  ICMJE 262.255
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP