NCT Number: NCT02180477
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
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.
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Notify MeKey information
Conditions
Age range
20 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
UHAC 62 XX - TF2 tablet
DrugUHAC 62 XX - capsules
DrugPrimary outcomes
-
Cmax (Maximum observed concentration in plasma)
Time frame: 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
Secondary outcomes
-
tmax (Time to reach maximum concentration)
Time frame: up to 72 hours after administration
-
t1/2 (Terminal half-life in plasma)
Time frame: 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
-
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
-
Number of patients with adverse events
Time frame: up to 14 days after last administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation
Important dates
- Study start
- 2001
- Primary completion
- 2001
- First posted
- Jul 2, 2014
- Registry last updated
- Jul 8, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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