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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

• Registration Number: NCT02276352
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-06
• Primary Completion: 1999-08
• Status Verified: 2014-05
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-27
• Last Update Submitted: 2014-10-27
• Study First Posted: 2014-10-28
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 %

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meloxicam low dose - one tablet	Treatment 1	-
Meloxicam high dose - two tablets	Treatment 2	-
Meloxicam high dose - one tablet	Treatment 3	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	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-∞)	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 Outcome Measures

Name	Time	Method
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)	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 )	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)	predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
Time from dosing to the maximum concentration of the analyte in plasma (tmax)	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)	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)	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)	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	predose, up to 96:00 h post dose
Number of patients with abnormal findings in systolic and diastolic blood pressure	predose, up to 96:00 h post dose
Number of patients with adverse events	up to 39 days
Number of patients with abnormal changes in laboratory parameters	predose, up to 96:00 h post dose