- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180477
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
July 4, 2014 updated by: Boehringer Ingelheim
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UHAC 62 XX TF1 tablet
|
|
Experimental: UHAC 62 XX TF2 tablet
|
|
Active Comparator: UHAC 62 XX capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (Maximum observed concentration in plasma)
Time Frame: up to 72 hours after administration
|
up to 72 hours after administration
|
AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)
Time Frame: up to 72 hours after administration
|
up to 72 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tmax (Time to reach maximum concentration)
Time Frame: up to 72 hours after administration
|
up to 72 hours after administration
|
t1/2 (Terminal half-life in plasma)
Time Frame: up to 72 hours after administration
|
up to 72 hours after administration
|
AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)
Time Frame: up to 72 hours after administration
|
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)
Time Frame: up to 72 hours after administration
|
up to 72 hours after administration
|
Number of patients with adverse events
Time Frame: up to 14 days after last administration
|
up to 14 days after last administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
July 1, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 107.251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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