Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range

Boehringer Ingelheim24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Meloxicam - low doseDRUG

Meloxicam - medium doseDRUG

Meloxicam - high doseDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female subjects as determined by results of screening * Age range from 21 to 50 years * Broca-Index +- 20% * In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and 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) * Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or 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 one month or less than ten half-lives of the respective drug before enrolment in the study * Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial) * Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (\>= 100 mL within four weeks prior to administration or during the trial * Excessive physical activities (within the last week before study) * Anl laboratory value outside the reference range of 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