Clinical trial NCT02180477: Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
Official title: Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 9
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 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.


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 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

Primary outcomes:
measure: Cmax (Maximum observed concentration in plasma)
timeFrame: up to 72 hours after administration
measure: AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)
timeFrame: up to 72 hours after administration
Secondary outcomes:
measure: tmax (Time to reach maximum concentration)
timeFrame: up to 72 hours after administration
measure: t1/2 (Terminal half-life in plasma)
timeFrame: up to 72 hours after administration
measure: AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)
timeFrame: up to 72 hours after administration
measure: MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration)
timeFrame: up to 72 hours after administration
measure: Number of patients with adverse events
timeFrame: up to 14 days after last administration
Other outcomes:
Locations:
Study officials:
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