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OpenTrials
Completed

NCT Number: NCT02276352

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 %

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Treatment 1

Drug

Treatment 2

Drug

Treatment 3

Drug

Primary outcomes

  1. 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

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

    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

Secondary outcomes

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

    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

  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)

    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

  3. Apparent terminal elimination rate constant (λz )

    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

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

    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

  5. Mean residence time (MRTtot)

    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

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

    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

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

    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

  8. Number of patients with abnormal findings in pulse rate

    Time frame: predose, up to 96:00 h post dose

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

    Time frame: predose, up to 96:00 h post dose

  10. Number of patients with adverse events

    Time frame: up to 39 days

  11. Number of patients with abnormal changes in laboratory parameters

    Time frame: predose, up to 96:00 h post dose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
1999
Primary completion
1999
First posted
Oct 28, 2014
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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