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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Treatment 2

Drug: Treatment 3

Drug: Treatment 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT02276352

107.226

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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