Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects

Inclusion criteria

• Healthy subjects as determined by results of screening
• 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 laboratory, blood pressure, pulse rate and electrocardiogram (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
• Known alcohol abuse
• Known drug abuse
• Blood donation (≤ 1 month 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, IUD (intrauterine device), oral contraceptives
• Inability to maintain this adequate contraception during the whole study period
• Lactation period