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

NCT ID: NCT02183077

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meloxicam gel

Group Type: EXPERIMENTAL

Meloxicam gel

Intervention Type: DRUG

Meloxicam tablet

Group Type: ACTIVE_COMPARATOR

Meloxicam tablet

Intervention Type: DRUG

Interventions

Meloxicam gel

Intervention Type: DRUG

Meloxicam tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 %

Exclusion Criteria

• 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)
• History of hemorrhagic diatheses
• History of gastrointestinal ulcer, perforation or bleeding
• History of bronchial asthma
• Any laboratory value outside the normal range of clinical relevance
• History of dermatological diseases
• Skin disease and/or skin lesions at the site of planned application

For female subjects:

• Pregnancy
• Positive pregnancy test
• Breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

107.214

Identifier Type: -

Identifier Source: org_study_id