HealthyPhase 1NCT01361022
To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers
A Phase 1 study testing Lendormin tablet and Brotizolam tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Taiwan.
Trial summary
The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lendormin tablet and Brotizolam tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Nov 2011
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- Healthy adult male, aged between 20 and 40 years old.
- Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- No significant deviation from normal biochemistry examination.
- No significant deviation from normal haematology examination.
- No significant deviation from normal urinalysis examination.
Who cannot join
- History of drug or alcohol abuse within the past one year.
- Medical history of allergic asthma or sensitivity to analogous drug.
- Evidence of chronic or acute infectious diseases from 4 weeks before the study.
- Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- Ongoing peptic ulcer and constipation.
- Planned vaccination during the time course of the study.
Show all 11Show fewer
- Taking any clinical investigation drug from 3 months before the study.
- Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
- Donation of greater than 250 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
- A positive test for HIV(Human immunodeficiency virus) antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-dose, Two-way Cross-over Study to Assess the Bioequivalence of Lendormin Tablets 0.25 mg (Delpharm Reims) vs. Lendormin Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) Administered to Healthy Adult Volunteers
The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
- Conditions
- Healthy
- Being tested
- Lendormin tablet, Brotizolam tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lendormin tabletDrug
Lendormin tablet 250mc is administrated and compared
Brotizolam tabletDrug
Brotizolam tablet 250mc is administrated and compared
| Study group | Role | What they receive |
|---|---|---|
| Brotizolam tablet | Active comparator | Brotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively Receives: Drug: Brotizolam tablet |
| Lendormin tablet | Experimental | Lendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively Receives: Drug: Lendormin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Peak drug concentration obtained directly from the data without interpolation
Measured: One month
kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Measured: One month
Tmax:Time to peak drug concentration obtained directly from the data without interpolation
Measured: One month
T 1/2: Plasma half-life estimated by (0.693/kel)
Measured: One month
MRT : Mean residence time
Measured: One month
AUMC : Area under the ( first) moment plasma concentration - time curve
Measured: One month
AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule
Measured: One month
AUC 0- : Area under the plasma concentration-time curve from time zero to infinity determined by the trapezoidal rule and extrapolated to infinity estimated by the last quantifiable concentration (Cn) divided by kel
Measured: One month
Secondary outcomes (4)
Blood pressure
Measured: one month
heart rate
Measured: one month
body temperature
Measured: One month
12 Laed ECG, Lab Test ( Hematocrit, WBC count with differential, RBC count and platelet count ; SGOT ( AST), SGPT (ALT) , alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine,uric acid, total cholesterol and TG)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
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
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361022
- Sponsor's protocol ID
- 263.511
- Status last verified
- Oct 2013
- First submitted
- 25 May 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Two-way Cross-over Study to Assess the Bioequivalence of Lendormin Tablets 0.25 mg (Delpharm Reims) vs. Lendormin Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01361022
- Acronym / sponsor ID
- 263.511
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- First posted
- 26 May 2011 (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 objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brotizolam tablet | Active comparator | Drug: Brotizolam tabletBrotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively |
| Lendormin tablet | Experimental | Drug: Lendormin tabletLendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers, provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- Healthy adult male, aged between 20 and 40 years old.
- Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- No significant deviation from normal biochemistry examination.
Key exclusion criteria (11 listed)
- History of drug or alcohol abuse within the past one year.
- Medical history of allergic asthma or sensitivity to analogous drug.
- Evidence of chronic or acute infectious diseases from 4 weeks before the study.
- Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- Ongoing peptic ulcer and constipation.
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 |
|---|---|---|
| Lendormin tabletLendormin tablet 250mc is administrated and compared | Drug | Lendormin tablet |
| Brotizolam tabletBrotizolam tablet 250mc is administrated and compared | Drug | Brotizolam tablet |
Primary outcome
Cmax: Peak drug concentration obtained directly from the data without interpolation
Time frame: One month
kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Time frame: One month
Tmax:Time to peak drug concentration obtained directly from the data without interpolation
Time frame: One month
T 1/2: Plasma half-life estimated by (0.693/kel)
Time frame: One month
MRT : Mean residence time
Time frame: One month
AUMC : Area under the ( first) moment plasma concentration - time curve
Time frame: One month
AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule
Time frame: One month
AUC 0- : Area under the plasma concentration-time curve from time zero to infinity determined by the trapezoidal rule and extrapolated to infinity estimated by the last quantifiable concentration (Cn) divided by kel
Time frame: One month
4 secondary outcomes
Blood pressure
Time frame: one month
heart rate
Time frame: one month
body temperature
Time frame: One month
12 Laed ECG, Lab Test ( Hematocrit, WBC count with differential, RBC count and platelet count ; SGOT ( AST), SGPT (ALT) , alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine,uric acid, total cholesterol and TG)
Time frame: One month
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 1 Nov 2013.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lendormin tablet and Brotizolam tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Taiwan.
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 7 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cmax: Peak drug concentration obtained directly from the data without interpolation (time frame: One month). The study lists 8 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 1 Nov 2013.