Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183077
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.

Condition or disease Intervention/treatment Phase
Healthy Drug: Meloxicam gel Drug: Meloxicam tablet Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study
Study Start Date : September 1998
Actual Primary Completion Date : November 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam gel Drug: Meloxicam gel
Active Comparator: Meloxicam tablet Drug: Meloxicam tablet



Primary Outcome Measures :
  1. Analysis of plasma concentration-time course after topical dose [ Time Frame: up to 264 hours after first topical administration ]
  2. Determination of the ratio AUCss topical/AUC0-∞ oral [ Time Frame: up to 96 hours after oral administration ]

Secondary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: up to 96 hours after oral administration ]
  2. Time from dosing to the maximum concentration of the analyte in plasma (Tmax) [ Time Frame: up to 96 hours after oral administration ]
  3. 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: up to 96 hours after oral administration ]
  4. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 96 hours after oral administration ]
  5. Terminal half-life of the analyte in plasma (t½) [ Time Frame: up to 96 hours after oral administration ]
  6. Apparent terminal elimination rate constant [ Time Frame: up to 96 hours after oral administration ]
  7. Apparent clearance of the analyte in plasma following extravascular administration (CL/F) [ Time Frame: up to 96 hours after oral administration ]
  8. Apparent volume of distribution of the analyte during the terminal phase (Vz/F) [ Time Frame: up to 96 hours after oral administration ]
  9. Mean residence time (MRTtot) [ Time Frame: up to 96 hours after oral administration ]
  10. Excretion of metabolites in urine [ Time Frame: 0-24 hours after oral administration ]
  11. Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) [ Time Frame: up to 264 hours after first topical administration ]
  12. Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [ Time Frame: up to 264 hours after first topical administration ]
  13. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [ Time Frame: up to 264 hours after first topical administration ]
  14. Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss) [ Time Frame: up to 264 hours after first topical administration ]
  15. Terminal half-life of the analyte in plasma (t½) [ Time Frame: up to 264 hours after first topical administration ]
  16. Apparent terminal elimination rate constant [ Time Frame: up to 264 hours after first topical administration ]
  17. Occurence of adverse events [ Time Frame: up to 24 days ]
  18. Assessment of local and systemic tolerability [ Time Frame: up to 24 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • Hypersensitivity to meloxicam and any of the excipients 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
  • Known alcohol abuse
  • Known drug abuse
  • Blood donation (<= 1 months prior to administration)
  • Excessive physical activities (<= 5 days prior to administration)
  • History of hemorrhagic diatheses
  • History of gastrointestinal ulcer, perforation or bleeding
  • History of bronchial asthma
  • Any laboratory value outside the normal range of clinical relevance
  • History of dermatological diseases
  • Skin disease and/or skin lesions at the site of planned application

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • Breast feeding

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183077    
Other Study ID Numbers: 107.214
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action