HealthyPhase 1NCT02181322
Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range
A Phase 1 study testing Meloxicam - low dose, Meloxicam - medium dose and Meloxicam - high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meloxicam - low dose, Meloxicam - medium dose and Meloxicam - high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Sep 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Age range from 21 to 50 years
- Broca-Index +- 20%
- In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 26Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (>= 100 mL within four weeks prior to administration or during the trial
- Excessive physical activities (within the last week before study)
- Anl laboratory value outside the reference range of clinical relevance
- History of haemorrhagic diatheses
- History of gastrointestinal ulcer, perforation or bleeding
- History of bronchial asthma
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g sterilisation, intrauterine pessary, oral contraceptives
- Inability to maintain this adequate contraception during the whole study period
- Lactating
About this study
Official title: An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg.
Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg
- Conditions
- Healthy
- Being tested
- Meloxicam - low dose, Meloxicam - medium dose, Meloxicam - high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam - low doseDrug
Meloxicam - medium doseDrug
Meloxicam - high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam - low dose, fasted | Experimental | Not described Receives: Drug: Meloxicam - low dose |
| Meloxicam - medium dose, fasted | Experimental | Not described Receives: Drug: Meloxicam - medium dose |
| Meloxicam - high dose, fasted | Experimental | Not described Receives: Drug: Meloxicam - high dose |
| Meloxicam - high dose, fed | Experimental | Not described Receives: Drug: Meloxicam - high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 96 hours after drug administration
AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 96 hours after drug administration
Secondary outcomes (8)
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 96 hours after drug administration
AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration)
Measured: up to 96 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 96 hours after drug administration
Terminal rate constant in plasma
Measured: up to 96 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 96 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Measured: up to 96 hours after drug administration
MRTtot (Total mean residence time)
Measured: up to 96 hours after drug administration
Number of patients with adverse events
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2001
- Primary completionSep 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
- 24 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
- NCT02181322
- Sponsor's protocol ID
- 107.243
- Status last verified
- Jul 2014
- First submitted
- 2 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
- An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg.
- ClinicalTrials.gov ID
- NCT02181322
- Acronym / sponsor ID
- 107.243
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Sep 2001 (actual)
- First posted
- 3 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 assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meloxicam - low dose, fasted | Experimental | Drug: Meloxicam - low dose |
| Meloxicam - medium dose, fasted | Experimental | Drug: Meloxicam - medium dose |
| Meloxicam - high dose, fasted | Experimental | Drug: Meloxicam - high dose |
| Meloxicam - high dose, fed | Experimental | Drug: Meloxicam - high dose |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects as determined by results of screening
- Age range from 21 to 50 years
- Broca-Index +- 20%
- In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Meloxicam - low dose | Drug | Meloxicam - low dose, fasted |
| Meloxicam - medium dose | Drug | Meloxicam - medium dose, fasted |
| Meloxicam - high dose | Drug | Meloxicam - high dose, fasted, Meloxicam - high dose, fed |
Primary outcome
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
8 secondary outcomes
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration)
Time frame: up to 96 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
Terminal rate constant in plasma
Time frame: up to 96 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 96 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 96 hours after drug administration
MRTtot (Total mean residence time)
Time frame: up to 96 hours after drug administration
Number of patients with adverse events
Time frame: up to 10 weeks
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.
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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 Meloxicam - low dose, Meloxicam - medium dose and Meloxicam - high dose 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 26 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?
Cmax (Maximum measured concentration of the analyte in plasma) (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.