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CompletedNCT02260063Updated Oct 9, 2014

Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

A Phase 1 interventional study of Epinastine syrup and Epinastine tablets in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-09.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study summary

To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • male and female, non-smoker and non-alcohol user, healthy volunteers, of 21 - 45 years of age. To be eligible, women must not be pregnant or lactating and they must not be taking hormone contraceptives
  • Volunteers must not have a history of liver or renal disease or a history of psychiatric disorder. Volunteers will be submitted to the biochemical tests listed below, the results of which must be within expected normal values: complete blood count, erythro-sedimentation rate, GOT (glutamate oxalacetate transaminase) GPT (glutamate pyruvate transaminase), blood creatinine, glycemia, uremia, blood cholesterol, pregnancy test. HIV test (with prior written consent), serum tests for Chagas disease, hepatic b and syphilis, complete urinalysis, ECG (electrocardiogram) and chest x-ray
  • Volunteers must have discontinued all pharmacological treatment at least two weeks before entering this trial
  • informed written consent, signed prior to the start of this trial

Exclusion criteria

Exclusion Criteria:

  • Volunteers requiring any kind of pharmacological treatment or having some known addiction
  • Volunteers having participated in any other clinical trial during the four preceding weeks
  • Volunteers who must start a treatment incompatible with this trial during its course
  • Volunteers who do not comply with the fasting requirements established in the trial or who do not comply with trial requirements such as avoiding intake of coffee, tea, cola soft drinks, etc. for 24 hours prior to the start of the trial
  • History of allergy or intolerance to Epinastine
  • Uncooperative volunteers
  • Previous participation in this trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Epinastine syrup

    Drug: Epinastine syrup

  • Active comparator
    Epinastine tablets

    Drug: Epinastine tablets

Interventions

  • DrugEpinastine syrup
  • DrugEpinastine tablets
06

What researchers measure

Primary outcomes

  1. Area under the curve (AUC) of plasma concentration (CP)

    Time frame: Up to 24 hours after drug administration

  2. Absorption rate Cpmax/AUC

    Time frame: Up to 24 hours after drug administration

Secondary outcomes

  1. Peak plasma concentration (Cpmax)

    Time frame: Up to 24 hours after drug administration

  2. Time to peak (Tmax)

    Time frame: Up to 24 hours after drug administration

  3. Drug half - life (T1/2)

    Time frame: Up to 24 hours after drug administration

  4. Number of participants with adverse events

    Time frame: Up to 24 hours after last drug administration

  5. Number of participants withdrawn or discontinued due to safety reasons

    Time frame: Up to 24 hours after last drug administration

  6. Number of participants with abnormal findings in physical examination

    Time frame: Up to 24 hours after last drug administration

  7. Number of participants with clinically significant findings in vital signs

    Time frame: Up to 24 hours after last drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02260063
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 9, 2014
Start date
Nov 1998
Primary completion
Jan 1999
Last update
Oct 9, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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