NCT Number: NCT02181907
Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers
Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
Looking for future studies?
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 : Body Mass Index ≥ 18.5 and < 25
- 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 to this study by written informed consent
Exclusion criteria
- History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
- History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
- History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- A tendency of bleeding
- History of alcohol or drug abuse
- Taking 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 trial
- Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
- Any medication which could 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 were judged by the investigator to be inappropriate as the subjects of the study
Treatment and study plan
UH-AC 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
-
MRTpo (Mean residence time of the analyte in the body after single dose po administration)
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 UH-AC 62 XX Tablets 10 mg (TF4) Compared With the 10 mg Capsule Formulations Following Single Peroral Administration in Healthy Volunteers
Important dates
- Study start
- 2003
- Primary completion
- 2003
- First posted
- Jul 8, 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details