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

Pharmacokinetics and Tolerability of a Single 15mg Meloxicam Dose Injected Intramuscularly Compared to a Single Oral 15 mg Meloxicam Tablet in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study.

Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet

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