Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
1 other identifier
interventional
9
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedJuly 8, 2014
July 1, 2014
1 month
July 1, 2014
July 4, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
tmax (Time to reach maximum concentration)
up to 72 hours after administration
t1/2 (Terminal half-life in plasma)
up to 72 hours after administration
AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)
up to 72 hours after 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
Number of patients with adverse events
up to 14 days after last administration
Study Arms (3)
UHAC 62 XX TF1 tablet
EXPERIMENTALUHAC 62 XX TF2 tablet
EXPERIMENTALUHAC 62 XX capsule
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
November 1, 2001
Primary Completion
December 1, 2001
Last Updated
July 8, 2014
Record last verified: 2014-07