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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1999

Interventions

  • Drug: Treatment 1
  • Drug: Treatment 2
  • Drug: Treatment 3

Arms, Groups and Cohorts

  • Experimental: Meloxicam low dose – one tablet
  • Experimental: Meloxicam high dose – two tablets
  • Active Comparator: Meloxicam high dose – one tablet

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Number of patients with abnormal findings in pulse rate
    • Time Frame: predose, up to 96:00 h post dose
  • Number of patients with abnormal findings in systolic and diastolic blood pressure
    • Time Frame: predose, up to 96:00 h post dose
  • Number of patients with adverse events
    • Time Frame: up to 39 days
  • Number of patients with abnormal changes in laboratory parameters
    • Time Frame: predose, up to 96:00 h post dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.