Healthy
Conditions
Brief summary
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \>= 20 and \<= 35 years * Weight: Body Mass Index \>= 18.5 and \< 25 * Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test * Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
Exclusion criteria
* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy) * History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or Non-steroidal anti-inflammatory drugs (NSAIDs) * History of aspirin induced asthma (bronchial asthma induced by NSAIDs) * History of bleeding tendency * History of alcohol or drug abuse * Participation to another trial with an investigational drug within 4 months prior to the trial * Whole blood donation more than 400 ml within 3 months prior to the trial * Whole blood donation more than 100 ml within 1 month prior to the trial * Donation of constituent of blood of more than 400 ml within 1 month prior to the trial * Any medication which might influence the results of the trial within 10 days prior to the trial * Excessive physical activities within 7 days prior to the trial * Alcohol drinking within 3 days prior to the trial * History of orthostatic hypotension, fainting spells or blackouts * Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum observed concentration of the analyte in plasma) | up to day 8 |
| AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration) | up to day 8 |
Secondary
| Measure | Time frame |
|---|---|
| MRT 0-τ (Mean residence time in the body after 7-day administration) | up to day 8 |
| Tmax (Time to reach Cmax) | up to day 8 |
| Number of patients with adverse events | up to 20 days after final administration |
| Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration) | up to day 8 |
| T1/2 (Terminal half-life in plasma) | up to day 8 |
Outcome results
None listed