Clinical trial NCT02180490: Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers
Official title: Bioequivalence Study of UHAC 62 XX 10 mg Tablets Compared With 10 mg Capsules Following Single Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) in fasted state.


Eligibility criteria: 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 UHAC 62 XX and/or salicylate (aspirin) 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 administration
* 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

Primary outcomes:
measure: Cmax (Maximum observed concentration of the analyte in plasma)
timeFrame: up to 60 hours after drug administration
measure: AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)
timeFrame: up to 60 hours after drug administration
Secondary outcomes:
measure: Tmax (Time to reach Cmax)
timeFrame: up to 60 hours after drug administration
measure: t1/2 ( Terminal half-life of the analyte in plasma)
timeFrame: up to 60 hours after drug administration
measure: AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)
timeFrame: up to 60 hours after drug administration
measure: MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity)
timeFrame: up to 60 hours after drug administration
measure: Number of patients with adverse events
timeFrame: up to 20 days after final drug administration
Other outcomes:
Locations:
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