Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects

This is an interventional treatment trial for Healthy Read More

Inclusion Criteria:

• Healthy male or female subjects between the ages of 18 and 55 years
• Negative urine pregnancy test on Day1 for females of childbearing potential
• Weight within +/- 20 percent of ideal weight according to the Metropolitan Life Height and Weight chart
• Willing and able to cooperate with the investigator and his/her staff
• Written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

• Any finding, medical condition or dietary restriction that, in the investigator's opinion, may interfere with optimal participation in the study or produce a significant risk to the subject
• In the opinion of the investigator, the subject has any disease or condition that may result in altered absorption, excess accumulation, or impaired metabolism or excretion of the trial medications
• A known or suspected hypersensitivity to any of the trial medications or their excipients or any other NSAIDs (Non-Steroid Anti-Inflammatory Drug)
• A history of gastrointestinal ulcer, perforation or bleeding
• A history of cerebrovascular bleeding or any other bleeding disorder
• Women of childbearing potential not using adequate contraception (e.g, intrauterine device, contraceptive pills, Depo-Provera® implant, barrier device) for at least 3 months prior to, and for the duration of trial participation. It should be noted that NSAIDs may interfere with the effectiveness of intrauterine devices
• History of bronchial asthma
• Use of any medications that might influence the results of the trial
• Use of anticoagulants, including warfarin, heparin, ticlopidine, clopidogrel or aspirin

• Any laboratory value outside the normal range that is considered clinically significant by the investigator. In addition, subjects with the following specific laboratory values will not be allowed:

  • A serum creatinine concentration at baseline > 1.5 mg/dl
  • SGOT (serum glutamic-oxaloacetic transaminase) or SGPT (serum glutamic-pyruvic transaminase) liver enzymes results at baseline > 1.5 times the upper limit of normal
  • A hemoglobin concentration < 10.5 g/dl
  • A white cell count < 3500/mm³
  • A platelet < 100,000/mm³ or a documented abnormal bleeding time, platelet aggregation, thromboxane B2 synthesis, thromboplastin time (PT) or activated partial thromboplastin time (APTT)
• Inability to refrain from smoking on testing days
• Participation in another trial with an investigational drug within 30 days of entering the trial
• Subjects with increased keloid formation
• Previous surgery of the gastrointestinal tract (except appendectomy)
• Participation in excessive physical activities (≤ 5 days prior to administration)
• Current drug or alcohol abuse
• Small or difficult to locate arm veins that would impair the clinician's ability to draw blood samples
• Homeopathic medication