NCT Number: NCT02181322
Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range
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
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Conditions
Age range
21 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Meloxicam - medium dose
DrugMeloxicam - high dose
DrugPrimary outcomes
-
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
-
AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
Secondary outcomes
-
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
-
AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration)
Time frame: up to 96 hours after drug administration
-
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
-
Terminal rate constant in plasma
Time frame: up to 96 hours after drug administration
-
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 96 hours after drug administration
-
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 96 hours after drug administration
-
MRTtot (Total mean residence time)
Time frame: up to 96 hours after drug administration
-
Number of patients with adverse events
Time frame: up to 10 weeks
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg.
Important dates
- Study start
- 2001
- Primary completion
- 2001
- First posted
- Jul 3, 2014
- Registry last updated
- Jul 8, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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