NCT02182531

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1999

Completed
14.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

July 2, 2014

Last Update Submit

July 11, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Epinastine and Pseudoephedrine combination

EXPERIMENTAL
Drug: EpinastineDrug: PseudoephedrineDrug: Epinastine + Pseudoephedrine combination

Epinastine

ACTIVE COMPARATOR
Drug: EpinastineDrug: PseudoephedrineDrug: Epinastine + Pseudoephedrine combination

Pseudoephedrine

ACTIVE COMPARATOR
Drug: EpinastineDrug: PseudoephedrineDrug: Epinastine + Pseudoephedrine combination

Interventions

EpinastineDRUG
EpinastineEpinastine and Pseudoephedrine combinationPseudoephedrine
PseudoephedrineDRUG
EpinastineEpinastine and Pseudoephedrine combinationPseudoephedrine
Epinastine + Pseudoephedrine combinationDRUG
EpinastineEpinastine and Pseudoephedrine combinationPseudoephedrine

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

epinastinePseudoephedrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 8, 2014

Study Start

August 1, 1999

Primary Completion

October 1, 1999

Last Updated

July 14, 2014

Record last verified: 2014-07