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Completed

NCT Number: NCT02181322

Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range

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

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Key information

Conditions

Age range

21 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 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Meloxicam - low dose

Drug

Meloxicam - medium dose

Drug

Meloxicam - high dose

Drug

Primary outcomes

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

    Time frame: up to 96 hours after drug administration

  2. 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

Secondary outcomes

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

    Time frame: up to 96 hours after drug administration

  2. 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

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

    Time frame: up to 96 hours after drug administration

  4. Terminal rate constant in plasma

    Time frame: up to 96 hours after drug administration

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

    Time frame: up to 96 hours after drug administration

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

    Time frame: up to 96 hours after drug administration

  7. MRTtot (Total mean residence time)

    Time frame: up to 96 hours after drug administration

  8. Number of patients with adverse events

    Time frame: up to 10 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2001
First posted
Jul 3, 2014
Registry last updated
Jul 8, 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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