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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: meloxicam rapid release tablet, 12mg, UH AC62MU

Study type

Interventional

Funder types

Industry

Identifiers

107.224

Details and patient eligibility

About

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

Enrollment

8 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 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