A Phase 1 interventional study of Barcimiant and Olumiant (first dose) in Healthy, sponsored by Genuine Research Center, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Genuine Research Center, Egypt · Phase 1, Interventional, and Other
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Baricitinib from Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
Genuine Research Center, Egypt is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Test drug (Barcimiant) 1 tablet contains 4 mg Baricitinib
Drug: Barcimiant
Reference drug (Olumiant) 1 tablet contains 4 mg Baricitinib
Drug: Olumiant (first dose)
Reference drug (Olumiant) 1 tablet contains 4 mg Baricitinib
Drug: Olumiant (second dose)
1 tablet contains 4 mg Barcitinib
Also known as: Olumiant
1 tablet contains 4 mg Barcitinib
Also known as: Olumiant
1 tablet contains 4 mg Barcitinib
Also known as: Olumiant
Cmax
Maximal measured plasma concentration
Time frame: Up to 48 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Time frame: Up to 48 hours post dose in each treatment period
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Genuine Research Center, Egypt