Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam

Criteria

Inclusion Criteria:

• Healthy male or female subjects as determined by results of screening

• Age range from 21 to 50 years

• Broca index +/- 20%

• Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders

• Surgery of the gastro-intestinal tract (except appendectomy)

• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

• History of orthostatic hypotension, fainting spells and blackouts

• Chronic or relevant acute infections

• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

• Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than ten half-lives of the respective drug prior to administration

• Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during trial)

• Participation in another trial with an investigational drug within 2 months prior to administration or during trial

• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)

• Inability to refrain from smoking on study days

• Alcohol abuse (> 60 g/day)

• Drug abuse

• Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)

• Excessive physical activities (within the last week before the study)

• Any laboratory value outside the reference range or clinical relevance

• History of haemorrhagic diatheses

• History of gastrointestinal ulcer, perforation or bleeding

• History of bronchial asthma

For female subjects:

• Pregnancy

• Positive pregnancy test

• No adequate contraception e.g. sterilisation, intrauterine pessary, oral contraceptives

• Inability to maintain this adequate contraception during the whole study period

• Lactating