HealthyPhase 1NCT02182531
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers
A Phase 1 study testing Epinastine, Pseudoephedrine and Epinastine + Pseudoephedrine combination in people with Healthy, run by Boehringer Ingelheim.
Trial 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. 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, Pseudoephedrine and Epinastine + Pseudoephedrine combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Oct 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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 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.
- Conditions
- Healthy
- Being tested
- Epinastine, Pseudoephedrine, Epinastine + Pseudoephedrine combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinastineDrug
PseudoephedrineDrug
Epinastine + Pseudoephedrine combinationDrug
| Study group | Role | What they receive |
|---|---|---|
| Epinastine and Pseudoephedrine combination | Experimental | Not described Receives: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination |
| Epinastine | Active comparator | Not described Receives: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination |
| Pseudoephedrine | Active comparator | Not described Receives: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Epinastine + Pseudoephedrine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the analyte in plasma
Measured: 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)
Measured: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Secondary outcomes (6)
Peak plasma concentration (Cpmax)
Measured: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Tmax (Time to reach Cpmax)
Measured: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
T1/2 (Drug half-life)
Measured: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose
Number of patients with adverse events
Measured: up to 15 days
Number of withdrawals and discontinuations due to safety reasons
Measured: up to 15 days
Number of patients with clinically significant changes in vital signs
Measured: Baseline, day 1, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 1999
- Primary completionOct 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
- 25 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
- NCT02182531
- Sponsor's protocol ID
- 262.255
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02182531
- Acronym / sponsor ID
- 262.255
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Oct 1999 (actual)
- First posted
- 8 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epinastine and Pseudoephedrine combination | Experimental | Drug: Epinastine, Drug: Pseudoephedrine, Drug: Epinastine + Pseudoephedrine combination |
| Epinastine | Active comparator | Drug: Epinastine, Drug: Pseudoephedrine, Drug: Epinastine + Pseudoephedrine combination |
| Pseudoephedrine | Active comparator | Drug: Epinastine, Drug: Pseudoephedrine, Drug: Epinastine + Pseudoephedrine combination |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 | Drug | Epinastine, Epinastine and Pseudoephedrine combination, Pseudoephedrine |
| Pseudoephedrine | Drug | Epinastine, Epinastine and Pseudoephedrine combination, Pseudoephedrine |
| Epinastine + Pseudoephedrine combination | Drug | Epinastine, Epinastine and Pseudoephedrine combination, Pseudoephedrine |
Primary outcome
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
6 secondary outcomes
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
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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, Pseudoephedrine and Epinastine + Pseudoephedrine combination 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 5 inclusion and 11 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 14 Jul 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 the analyte in plasma (time frame: Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose). 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 14 Jul 2014.