Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

Boehringer Ingelheim24 enrolled

Overview

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.

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% * 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