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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Meloxicam tablet; Drug: Meloxicam ampoule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183090

107.217

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Meloxicam ampoule

Experimental group

Treatment:

Drug: Meloxicam ampoule

Meloxicam tablet

Active Comparator group

Treatment:

Drug: Meloxicam tablet