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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam

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