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

• ClinicalTrials.gov Identifier: NCT02276352
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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.
• Study Start Date: June 1999
• Actual Primary Completion Date: August 1999

Arms and Interventions

Arm	Intervention/treatment
Experimental: Meloxicam low dose - one tablet	Drug: Treatment 1
Experimental: Meloxicam high dose - two tablets	Drug: Treatment 2
Active Comparator: Meloxicam high dose - one tablet	Drug: Treatment 3

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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 ]
8. Number of patients with abnormal findings in pulse rate [ Time Frame: predose, up to 96:00 h post dose ]
9. Number of patients with abnormal findings in systolic and diastolic blood pressure [ Time Frame: predose, up to 96:00 h post dose ]
10. Number of patients with adverse events [ Time Frame: up to 39 days ]
11. Number of patients with abnormal changes in laboratory parameters [ Time Frame: predose, up to 96:00 h post dose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02276352
• Other Study ID Numbers: 107.226
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Last Verified: May 2014