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

NCT ID: NCT02183103

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

meloxicam rapid release tablet after an overnight fast

Group Type: ACTIVE_COMPARATOR

meloxicam rapid release tablet, 12mg, UH AC62MU

Intervention Type: DRUG

meloxicam rapid release tablet after high fat breakfast

Group Type: EXPERIMENTAL

meloxicam rapid release tablet, 12mg, UH AC62MU

Intervention Type: DRUG

Interventions

meloxicam rapid release tablet, 12mg, UH AC62MU

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 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

107.224

Identifier Type: -

Identifier Source: org_study_id