A Phase 1 interventional study of Mobic, China, 7.5 mg and Mobic, Germany, 7.5 mg in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Mobic, China, 7.5 mg · Drug: Mobic, Germany, 7.5 mg
Drug: Mobic, China, 7.5 mg · Drug: Mobic, Germany, 7.5 mg
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
Time frame: Up to 96 hours after drug administration
Time to achieve Cmax (tmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
Time frame: Up to 96 hours after drug administration
Terminal rate constant in plasma (λ)
Time frame: Up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 96 hours after drug administration
Mean residence time of the analyte (MRT)
Time frame: Up to 96 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution following extravascular administration (Vd/F)
Time frame: Up to 96 hours after drug administration
Number of patients with clinically relevant changes from baseline in laboratory values
Time frame: Baseline, up to day 5 after last drug administration
Number of Participants with Adverse Events
Time frame: Up to day 5 after last drug administration
Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)
Time frame: Baseline, up to day 5 after last drug administration
Global assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5 after last drug administration
No study locations are listed for this record.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim