NCT Number: NCT02180490
Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers
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.
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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 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
Treatment and study plan
UHAC 62 XX capsule
DrugPrimary outcomes
-
Cmax (Maximum observed concentration of the analyte in plasma)
Time frame: up to 60 hours after drug administration
-
AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)
Time frame: up to 60 hours after drug administration
Secondary outcomes
-
Tmax (Time to reach Cmax)
Time frame: up to 60 hours after drug administration
-
t1/2 ( Terminal half-life of the analyte in plasma)
Time frame: up to 60 hours after drug administration
-
AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)
Time frame: up to 60 hours after drug administration
-
MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity)
Time frame: up to 60 hours after drug administration
-
Number of patients with adverse events
Time frame: up to 20 days after final drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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)
Important dates
- Study start
- 2002
- Primary completion
- 2002
- 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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