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 Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Meloxicam - high dose; Drug: Meloxicam - low dose; Drug: Meloxicam - medium dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181322

107.243

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Meloxicam - low dose, fasted

Experimental group

Treatment:

Drug: Meloxicam - low dose

Meloxicam - medium dose, fasted

Experimental group

Treatment:

Drug: Meloxicam - medium dose

Meloxicam - high dose, fasted

Experimental group

Treatment:

Drug: Meloxicam - high dose

Meloxicam - high dose, fed

Experimental group

Treatment:

Drug: Meloxicam - high dose