HealthyPhase 1NCT02218645
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males
A Phase 1 study testing WE 941 OD tablets and Brotizolam in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- WE 941 OD tablets and Brotizolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Sep 2000
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 35 years
- Weight between 50 and 80 kg
- Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
- Judged as eligible as a study object following the screening test by the investigator
- Volunteers to participate in the study, who are capable of giving written informed consent
Who cannot join
- Known hypersensitivity to drugs
- History of drug or alcohol abuse
- Received other investigational drug within 4 months of the trial drug administration
- Had > 400 mL of whole blood drawn within 3 months of the trial drug administration
- Had > 400 mL of blood components drawn within 1 month of the trial drug administration
- Used any drug within 10 days of the trial drug administration
Show all 9Show fewer
- Engaged in strenuous exercise within 5 days of the trial drug administration
- Consumed alcohol within 3 days of the trial drug administration
- Judged as ineligible for the study participation by the investigator for a reason other than above
About this study
Official title: The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis), Both Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.
- Conditions
- Healthy
- Being tested
- WE 941 OD tablets, Brotizolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE 941 OD tabletsDrug
BrotizolamDrug
Also called Lendormin®
| Study group | Role | What they receive |
|---|---|---|
| WE 941 OD | Experimental | Not described Receives: Drug: WE 941 OD tablets |
| Brotizolam | Active comparator | Not described Receives: Drug: Brotizolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
Measured: up to 24 hours after drug administration
Cmax (maximum plasma concentration)
Measured: up to 24 hours after drug administration
Secondary outcomes (3)
Number of patients with adverse events
Measured: up to 30 days
tmax (time to maximum plasma concentration)
Measured: up to 24 hours after drug administration
MRT (Mean residence time)
Measured: up to 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2000
- Primary completionSep 2000
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
- 30 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
- NCT02218645
- Sponsor's protocol ID
- 263.508
- Status last verified
- Aug 2014
- First submitted
- 15 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis), Both Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)
- ClinicalTrials.gov ID
- NCT02218645
- Acronym / sponsor ID
- 263.508
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Sep 2000 (actual)
- First posted
- 18 Aug 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.
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WE 941 OD | Experimental | Drug: WE 941 OD tablets |
| Brotizolam | Active comparator | Drug: Brotizolam |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 35 years
- Weight between 50 and 80 kg
- Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
- Judged as eligible as a study object following the screening test by the investigator
- Volunteers to participate in the study, who are capable of giving written informed consent
Key exclusion criteria (9 listed)
- Known hypersensitivity to drugs
- History of drug or alcohol abuse
- Received other investigational drug within 4 months of the trial drug administration
- Had > 400 mL of whole blood drawn within 3 months of the trial drug administration
- Had > 400 mL of blood components drawn within 1 month of the trial drug administration
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 |
|---|---|---|
| WE 941 OD tablets | Drug | WE 941 OD |
| BrotizolamAlso: Lendormin® | Drug | Brotizolam |
Primary outcome
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
Cmax (maximum plasma concentration)
Time frame: up to 24 hours after drug administration
3 secondary outcomes
Number of patients with adverse events
Time frame: up to 30 days
tmax (time to maximum plasma concentration)
Time frame: up to 24 hours after drug administration
MRT (Mean residence time)
Time frame: up to 24 hours after 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 18 Aug 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 WE 941 OD tablets and Brotizolam 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 9 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 18 Aug 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?
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours) (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 18 Aug 2014.