Healthy
Conditions
Brief summary
Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.
Interventions
DRUGUHAC 62 XX - TF1 tablet
DRUGUHAC 62 XX - TF2 tablet
DRUGUHAC 62 XX - capsules
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: BMI \>= 18.5 and \< 25 (Weight (kg) / Height (m²) * 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 meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs) * History of aspirin induced asthma (bronchial asthma induced by NSAIDs) * History of alcohol or drug abuse * Participation to another trial with an investigational drug within 4 months prior to the administration * Whole blood donation more than 400 ml within 3 months prior to the administration * Whole blood donation more than 100 ml within 1 month prior to the administration * Donation of constituent of blood of more than 400 ml within 1 month prior to the administration * Any medication within 10 days prior to the administration * Excessive physical activities within 7 days prior to the administration * Alcohol drinking within 3 days prior to the administration * 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 in plasma) | up to 72 hours after administration |
| AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours) | up to 72 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity) | up to 72 hours after administration |
| tmax (Time to reach maximum concentration) | up to 72 hours after administration |
| Number of patients with adverse events | up to 14 days after last administration |
| MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration) | up to 72 hours after administration |
| t1/2 (Terminal half-life in plasma) | up to 72 hours after administration |
Outcome results
None listed