HealthyPhase 1NCT02260063
Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers
A Phase 1 study testing Epinastine syrup and Epinastine tablets in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epinastine syrup and Epinastine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Jan 1999
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets
- Conditions
- Healthy
- Being tested
- Epinastine syrup, Epinastine tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinastine syrupDrug
Epinastine tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Epinastine syrup | Experimental | Not described Receives: Drug: Epinastine syrup |
| Epinastine tablets | Active comparator | Not described Receives: Drug: Epinastine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of plasma concentration (CP)
Measured: Up to 24 hours after drug administration
Absorption rate Cpmax/AUC
Measured: Up to 24 hours after drug administration
Secondary outcomes (7)
Peak plasma concentration (Cpmax)
Measured: Up to 24 hours after drug administration
Time to peak (Tmax)
Measured: Up to 24 hours after drug administration
Drug half - life (T1/2)
Measured: Up to 24 hours after drug administration
Number of participants with adverse events
Measured: Up to 24 hours after last drug administration
Number of participants withdrawn or discontinued due to safety reasons
Measured: Up to 24 hours after last drug administration
Number of participants with abnormal findings in physical examination
Measured: Up to 24 hours after last drug administration
Number of participants with clinically significant findings in vital signs
Measured: Up to 24 hours after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startNov 1998
- Primary completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260063
- Sponsor's protocol ID
- 262.252
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets
- ClinicalTrials.gov ID
- NCT02260063
- Acronym / sponsor ID
- 262.252
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Jan 1999 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinastine syrup | Experimental | Drug: Epinastine syrup |
| Epinastine tablets | Active comparator | Drug: Epinastine tablets |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinastine syrup | Drug | Epinastine syrup |
| Epinastine tablets | Drug | Epinastine tablets |
Primary outcome
Area under the curve (AUC) of plasma concentration (CP)
Time frame: Up to 24 hours after drug administration
Absorption rate Cpmax/AUC
Time frame: Up to 24 hours after drug administration
7 secondary outcomes
Peak plasma concentration (Cpmax)
Time frame: Up to 24 hours after drug administration
Time to peak (Tmax)
Time frame: Up to 24 hours after drug administration
Drug half - life (T1/2)
Time frame: Up to 24 hours after drug administration
Number of participants with adverse events
Time frame: Up to 24 hours after last drug administration
Number of participants withdrawn or discontinued due to safety reasons
Time frame: Up to 24 hours after last drug administration
Number of participants with abnormal findings in physical examination
Time frame: Up to 24 hours after last drug administration
Number of participants with clinically significant findings in vital signs
Time frame: Up to 24 hours after last drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epinastine syrup and Epinastine tablets in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of plasma concentration (CP) (time frame: Up to 24 hours after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.