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

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

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

• 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

• 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