HealthyPhase 1NCT02260050
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers
A Phase 1 study testing WAL 801 CL dry syrup new formulation and WAL 801 CL dry syrup conventional formulation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup 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?
- WAL 801 CL dry syrup new formulation and WAL 801 CL dry syrup conventional formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jul 2004
- 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
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature (BT)), 12-lead ECG, clinical laboratory tests (including gastric acidity (GA) test)
- No finding of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 20 and Age ≤ 35 years
- BMI ≥ 18.5 and BMI ≤ 25 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to Screening Phase and prior to Treatment Phase (Day -1 in Treatment period 1) in accordance with Japanese Good Clinical Practice (GCP)
Who cannot join
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History of surgery of gastrointestinal tract with the exception of appendectomy
- History of (and/or current) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Current chronic or relevant acute infections
- History of hypersensitivity (including drug allergy) or current allergic disorders which are deemed relevant to the trial by the investigator or the sub-investigators; e.g. bronchial asthma, allergic rhinitis, atopic dermatitis and food allergy (excluding asymptomatic seasonal rhinitis/hay fever)
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- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to drug administration and during Treatment Phase
- Use of any drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation, within 10 days prior to administration and during Treatment Phase
- Participation in Phase I trial of new chemical entities within 4 months prior to drug administration and during the trial, or in another clinical trial within 3 months prior to drug administration and during Treatment Phase
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking during hospitalization
- Alcohol abuse (more than 60 g/day) (confirmed by interview)
- Drug abuse (confirmed by interview)
- Whole blood donation (400 mL within 3 months or more than 100 mL within 4 weeks prior to drug administration or during the trial) or component blood donation (within 2 weeks prior to drug administration or during Treatment Phase)
- Excessive physical activities (within 48 hours prior to each treatment period and during hospitalisation)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
About this study
Official title: Bioequivalence of 20 mg of the New Formulation of WAL 801 CL Dry Syrup Compared to 20 mg of the Conventional Formulation of WAL 801 CL Dry Syrup Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, 2x2 Crossover Study)
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup
- Conditions
- Healthy
- Being tested
- WAL 801 CL dry syrup new formulation, WAL 801 CL dry syrup conventional formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAL 801 CL dry syrup new formulationDrug
WAL 801 CL dry syrup conventional formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| WAL 801 CL new formulation | Experimental | Not described Receives: Drug: WAL 801 CL dry syrup new formulation |
| WAL 801 CL conventional formulation | Active comparator | Not described Receives: Drug: WAL 801 CL dry syrup conventional formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz)
Measured: up to 34 hours after drug administration
Maximum measured concentration of the analytes in plasma (Cmax)
Measured: up to 34 hours after drug administration
Secondary outcomes (9)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 34 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 34 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Measured: up to 34 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 34 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Measured: up to 34 hours after drug administration
Number of patients with clinically significant findings in laboratory tests
Measured: up to 34 hours after last drug administration
Number of patients with clinically significant findings in physical examination
Measured: up to 34 hours after last drug administration
Number of patients with clinically significant findings in vital signs
blood pressure, pulse rate, body temperature
Measured: Up to 34 hours after last drug administration
Number of patients with adverse events
Measured: Up to 48 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 startJun 2004
- Primary completionJul 2004
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
- 34 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
- NCT02260050
- Sponsor's protocol ID
- 262.284
- Status last verified
- Oct 2014
- First submitted
- 7 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
- Bioequivalence of 20 mg of the New Formulation of WAL 801 CL Dry Syrup Compared to 20 mg of the Conventional Formulation of WAL 801 CL Dry Syrup Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, 2x2 Crossover Study)
- ClinicalTrials.gov ID
- NCT02260050
- Acronym / sponsor ID
- 262.284
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2004 (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 establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WAL 801 CL new formulation | Experimental | Drug: WAL 801 CL dry syrup new formulation |
| WAL 801 CL conventional formulation | Active comparator | Drug: WAL 801 CL dry syrup conventional formulation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males according to the following criteria:
- Age ≥ 20 and Age ≤ 35 years
- BMI ≥ 18.5 and BMI ≤ 25 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to Screening Phase and prior to Treatment Phase (Day -1 in Treatment period 1) in accordance with Japanese Good Clinical Practice (GCP)
Key exclusion criteria (17 listed)
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History of surgery of gastrointestinal tract with the exception of appendectomy
- History of (and/or current) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Current chronic or relevant acute infections
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 |
|---|---|---|
| WAL 801 CL dry syrup new formulation | Drug | WAL 801 CL new formulation |
| WAL 801 CL dry syrup conventional formulation | Drug | WAL 801 CL conventional formulation |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz)
Time frame: up to 34 hours after drug administration
Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: up to 34 hours after drug administration
9 secondary outcomes
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 34 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 34 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: up to 34 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 34 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 34 hours after drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 34 hours after last drug administration
Number of patients with clinically significant findings in physical examination
Time frame: up to 34 hours after last drug administration
Number of patients with clinically significant findings in vital signs
Time frame: Up to 34 hours after last drug administration
Number of patients with adverse events
Time frame: Up to 48 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 WAL 801 CL dry syrup new formulation and WAL 801 CL dry syrup conventional formulation 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 7 inclusion and 17 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 concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz) (time frame: up to 34 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.