HealthyPhase 1NCT02183142
Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers
A Phase 1 study testing Mobic, China, 7.5 mg and Mobic, Germany, 7.5 mg in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mobic, China, 7.5 mg and Mobic, Germany, 7.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Apr 2001
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy male volunteers as determined by result of screening
- Written informed consent in accordance with Good Clinical Practice (GCP)
- Age >= 18 and <= 40 years
- Broca > - 20% and < + 20%
Who cannot join
- Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- Hypersensitivity to Mobic and/or non-steroidal anti-inflammatory drugs
Show all 15Show fewer
- Intake any drugs within 1 month before randomization
- Participation in another trial with an investigational drug within the last 2 month or during the trial
- Smokers ( >= 10 cigarettes or >= 3 cigars or >= 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol or drug abuse
- Blood donation within the last 1 month
- Excessive physical activities within the last 5 days
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
About this study
Official title: Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial
The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
- Conditions
- Healthy
- Being tested
- Mobic, China, 7.5 mg, Mobic, Germany, 7.5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobic, China, 7.5 mgDrug
Mobic, Germany, 7.5 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Mobic Germany | Active comparator | Not described Receives: Drug: Mobic, China, 7.5 mg; Drug: Mobic, Germany, 7.5 mg |
| Mobic China | Experimental | Not described Receives: Drug: Mobic, China, 7.5 mg; Drug: Mobic, Germany, 7.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
Measured: Up to 96 hours after drug administration
Secondary outcomes (11)
Time to achieve Cmax (tmax)
Measured: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
Measured: Up to 96 hours after drug administration
Terminal rate constant in plasma (λ)
Measured: Up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 96 hours after drug administration
Mean residence time of the analyte (MRT)
Measured: Up to 96 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: Up to 96 hours after drug administration
Apparent volume of distribution following extravascular administration (Vd/F)
Measured: Up to 96 hours after drug administration
Number of patients with clinically relevant changes from baseline in laboratory values
Measured: Baseline, up to day 5 after last drug administration
Number of Participants with Adverse Events
Measured: Up to day 5 after last drug administration
Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)
Measured: Baseline, up to day 5 after last drug administration
Global assessment of tolerability by investigator on a 4-point scale
Measured: Day 5 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 posted8 Jul 2014 (estimated)
- Study startMar 2001
- Primary completionApr 2001
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
- 20 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
- NCT02183142
- Sponsor's protocol ID
- 107.234
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial
- ClinicalTrials.gov ID
- NCT02183142
- Acronym / sponsor ID
- 107.234
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Apr 2001 (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.
The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobic Germany | Active comparator | Drug: Mobic, China, 7.5 mg, Drug: Mobic, Germany, 7.5 mg |
| Mobic China | Experimental | Drug: Mobic, China, 7.5 mg, Drug: Mobic, Germany, 7.5 mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese healthy male volunteers as determined by result of screening
- Written informed consent in accordance with Good Clinical Practice (GCP)
- Age >= 18 and <= 40 years
- Broca > - 20% and < + 20%
Key exclusion criteria (15 listed)
- Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- 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 |
|---|---|---|
| Mobic, China, 7.5 mg | Drug | Mobic China, Mobic Germany |
| Mobic, Germany, 7.5 mg | Drug | Mobic China, Mobic Germany |
Primary outcome
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
Time frame: Up to 96 hours after drug administration
11 secondary outcomes
Time to achieve Cmax (tmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
Time frame: Up to 96 hours after drug administration
Terminal rate constant in plasma (λ)
Time frame: Up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 96 hours after drug administration
Mean residence time of the analyte (MRT)
Time frame: Up to 96 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution following extravascular administration (Vd/F)
Time frame: Up to 96 hours after drug administration
Number of patients with clinically relevant changes from baseline in laboratory values
Time frame: Baseline, up to day 5 after last drug administration
Number of Participants with Adverse Events
Time frame: Up to day 5 after last drug administration
Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)
Time frame: Baseline, up to day 5 after last drug administration
Global assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5 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 8 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 Mobic, China, 7.5 mg and Mobic, Germany, 7.5 mg 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 15 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 8 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?
Maximum measured concentration of the analyte in plasma (Cmax) (time frame: Up to 96 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 8 Jul 2014.