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

NCT02276352 | Completed Phase 1

• 1 other identifier: 107.226
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

• 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

• 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

Study Arms (3)

Meloxicam low dose - one tablet

EXPERIMENTAL

Drug: Treatment 1

Meloxicam high dose - two tablets

EXPERIMENTAL

Drug: Treatment 2

Meloxicam high dose - one tablet

ACTIVE COMPARATOR

Drug: Treatment 3

Interventions

Treatment 1 DRUG

Meloxicam low dose - one tablet

Treatment 2 DRUG

Meloxicam high dose - two tablets

Treatment 3 DRUG

Meloxicam high dose - one tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 28, 2014
• Study Start: June 1, 1999
• Primary Completion: August 1, 1999
• Last Updated: October 28, 2014

Record last verified: 2014-05