NCT Number: NCT02276352
Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers
Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg
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Notify MeKey information
Conditions
Age range
18 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 subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 50 years
- Broca >= -20% and <= + 20 %
Exclusion criteria
- Any finding of the medical examination (including laboratory 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)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
- Intake of drugs with a long half-life (>24 hours) (<= 1 month prior to administration or during the trial)
- 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)
- Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse
- Drug abuse
- Blood donation (<= 1 months prior to administration)
- Excessive physical activities (<= 5 days prior to administration)
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
For female subjects:
- 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
- Lactating
Treatment and study plan
Treatment 2
DrugTreatment 3
DrugPrimary outcomes
-
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
Secondary outcomes
-
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Apparent terminal elimination rate constant (λz )
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Terminal half-life of the analyte in plasma (t½)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Mean residence time (MRTtot)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Apparent volume of distribution of the analyte during the terminal phase (Vz/F)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
-
Number of patients with abnormal findings in pulse rate
Time frame: predose, up to 96:00 h post dose
-
Number of patients with abnormal findings in systolic and diastolic blood pressure
Time frame: predose, up to 96:00 h post dose
-
Number of patients with adverse events
Time frame: up to 39 days
-
Number of patients with abnormal changes in laboratory parameters
Time frame: predose, up to 96:00 h post dose
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
An Open, Randomized, Three-way Cross-over Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Meloxicam After Single p.o. Administration of 2 x 7.5 mg Meloxicam Tablets Compared to 15 mg Meloxicam Tablet, and Dose-proportionality Over a Dosage Range of 7.5 mg and 15 mg.
Important dates
- Study start
- 1999
- Primary completion
- 1999
- First posted
- Oct 28, 2014
- Registry last updated
- Oct 28, 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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