Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects

NCT02183077 | Completed Phase 1

• 1 other identifier: 107.214
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Analysis of plasma concentration-time course after topical dose

  up to 264 hours after first topical administration

• Determination of the ratio AUCss topical/AUC0-∞ oral

  up to 96 hours after oral administration

Secondary Outcomes (18)

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 96 hours after oral administration

• Time from dosing to the maximum concentration of the analyte in plasma (Tmax)

  up to 96 hours after oral administration

• 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)

  up to 96 hours after oral administration

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 96 hours after oral administration

• Terminal half-life of the analyte in plasma (t½)

  up to 96 hours after oral administration

Study Arms (2)

Meloxicam gel

EXPERIMENTAL

Drug: Meloxicam gel

Meloxicam tablet

ACTIVE COMPARATOR

Drug: Meloxicam tablet

Interventions

Meloxicam gel DRUG

Meloxicam gel

Meloxicam tablet DRUG

Meloxicam 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
• Signed written informed consent in accordance with Good Clinical Practice and local legislation
• Age \>= 18 and \<= 50 years
• Broca \>= -20% and \<= + 20 %

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• Hypersensitivity to meloxicam and any of the excipients 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
• Known alcohol abuse
• Known drug abuse
• Blood donation (\<= 1 months prior to administration)
• Excessive physical activities (\<= 5 days prior to administration)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: July 4, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 1998
• Primary Completion: November 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-07