Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects

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

Summary

Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam

Criteria

Inclusion Criteria:

• Healthy subjects as determined by results of screening

• Written informed consent according good clinical practice (GCP) and local legislation

• Age >=18 and <=50 years

• Broca >= -20% and <= +20%

Exclusion Criteria:

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

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder

• Surgery of gastro-intestinal tract (except appendectomy)

• Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder

• History of orthostatic hypotension, fainting spells or blackouts

• Chronic or relevant acute infections

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

• Intake of drugs with a long half-life ( >24h) (<=1month prior to administration)

• 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)

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

• Inability to refrain from smoking on trial days

• Alcohol abuse (>60g/day)

• Drug abuse

• Blood donation (<= 1 month prior to administration or during the trial)

• Excessive physical activities (<= 5 days prior to administration or during the trial)

• Any laboratory value outside the reference range of clinical relevance

• History of hemorrhagic diatheses

• History of gastro-intestinal ulcer, perforation or bleeding

• History of bronchial asthma

For female:

• Pregnancy

• Positive pregnancy test

• No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives

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

• Lactation period