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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Meloxicam gel; Drug: Meloxicam tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183077

107.214

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Meloxicam gel

Experimental group

Treatment:

Drug: Meloxicam gel

Meloxicam tablet

Active Comparator group

Treatment:

Drug: Meloxicam tablet