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HealthyPhase 1NCT02276352

Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers

A Phase 1 study testing Treatment 1, Treatment 2 and Treatment 3 in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Treatment 1, Treatment 2 and Treatment 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
Jun 1999to Aug 1999
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects as determined by results of screening
  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >= 18 and <= 50 years
  • Broca >= -20% and <= + 20 %

Who cannot join

  • Any finding of the medical examination (including laboratory 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)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
Show all 24Show fewer
  • Intake of drugs with a long half-life (>24 hours) (<= 1 month prior to administration or during the trial)
  • Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial)
  • Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse
  • Drug abuse
  • Blood donation (<= 1 months prior to administration)
  • Excessive physical activities (<= 5 days prior to administration)
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforation or bleeding
  • History of bronchial asthma
  • For female subjects:
  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
  • Inability to maintain this adequate contraception during the whole study period
  • Lactating

About this study

Official title: An Open, Randomized, Three-way Cross-over Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Meloxicam After Single p.o. Administration of 2 x 7.5 mg Meloxicam Tablets Compared to 15 mg Meloxicam Tablet, and Dose-proportionality Over a Dosage Range of 7.5 mg and 15 mg.

Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg

Conditions
Healthy
Being tested
Treatment 1, Treatment 2, Treatment 3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment 1Drug

  • Treatment 2Drug

  • Treatment 3Drug

Study groups in NCT02276352
Study groupRoleWhat they receive
Meloxicam low dose - one tabletExperimentalNot described
Receives: Drug: Treatment 1
Meloxicam high dose - two tabletsExperimentalNot described
Receives: Drug: Treatment 2
Meloxicam high dose - one tabletActive comparatorNot described
Receives: Drug: Treatment 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum measured concentration of the analyte in plasma (Cmax)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  2. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

Secondary outcomes (11)

  1. Time from dosing to the maximum concentration of the analyte in plasma (tmax)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  2. Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  3. Apparent terminal elimination rate constant (λz )

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  4. Terminal half-life of the analyte in plasma (t½)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  5. Mean residence time (MRTtot)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  6. Apparent clearance of the analyte in plasma following extravascular administration (CL/F)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  7. Apparent volume of distribution of the analyte during the terminal phase (Vz/F)

    Measured: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose

  8. Number of patients with abnormal findings in pulse rate

    Measured: predose, up to 96:00 h post dose

  9. Number of patients with abnormal findings in systolic and diastolic blood pressure

    Measured: predose, up to 96:00 h post dose

  10. Number of patients with adverse events

    Measured: up to 39 days

  11. Number of patients with abnormal changes in laboratory parameters

    Measured: predose, up to 96:00 h post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study startJun 1999
  3. Primary completionAug 1999

Resources

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276352
Sponsor's protocol ID
107.226
Status last verified
May 2014
First submitted
27 Oct 2014
Last updated
28 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment 1, Treatment 2 and Treatment 3 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 24 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 28 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?

Maximum measured concentration of the analyte in plasma (Cmax) (time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose). 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?

On the ClinicalTrials.gov record for NCT02276352.

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 28 Oct 2014.

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