Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

NCT ID: NCT02181309

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meloxicam low dose, fasted

Group Type: EXPERIMENTAL

Meloxicam, low dose

Intervention Type: DRUG

Meloxicam medium dose, fasted

Group Type: EXPERIMENTAL

Meloxicam, medium dose

Intervention Type: DRUG

Meloxicam high dose, fed

Group Type: EXPERIMENTAL

Meloxicam, high dose

Intervention Type: DRUG

Meloxicam high dose, fasted

Group Type: ACTIVE_COMPARATOR

Meloxicam, high dose

Intervention Type: DRUG

Interventions

Meloxicam, low dose

Intervention Type: DRUG

Meloxicam, medium dose

Intervention Type: DRUG

Meloxicam, high dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

107.254

Identifier Type: -

Identifier Source: org_study_id