Healthy
Conditions
Brief summary
Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
Interventions
DRUGUH-AC 62 XX tablet
DRUGUH-AC 62 XX capsule
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 to this study by written informed consent
Exclusion criteria
* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy) * History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs) * History of aspirin induced asthma (bronchial asthma induced by NSAIDs) * A tendency of bleeding * History of alcohol or drug abuse * Taking 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 could 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 were 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 60 hours after drug administration |
| AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours) | up to 60 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity) | up to 60 hours after drug administration |
| Tmax (Time to reach Cmax) | up to 60 hours after drug administration |
| Number of patients with adverse events | up to 20 days after final drug administration |
| MRTpo (Mean residence time of the analyte in the body after single dose po administration) | up to 60 hours after drug administration |
| t1/2 ( Terminal half-life of the analyte in plasma) | up to 60 hours after drug administration |
Outcome results
None listed