Clinical trial NCT05006768: Bioequivalence Study 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)
Official title: Comparative Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Genuine Research Center, Egypt
Sponsor class: INDUSTRY
Collaborators: name: Horus Pharma
First posted: 2021-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female, age 18 to 55 years, inclusive.
2. Enrolled study participants should have normal liver function tests, blood counts, and lipid profiles at baseline prior to study drug administration.
3. Clearly healthy males or females, as determined by medical history and physical examination.
4. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
5. Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
6. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
7. Females should be on a suitable birth control method.
8. Fully informed subjects that consented to participate in the study.

Exclusion Criteria:

1. Subjects with known allergy to the products tested.
2. Prospective study participants who are tested and confirmed positive for latent tuberculosis before enrolling in a bioequivalence study.
3. Have a current or recent history (less than \[\<\] 30 days prior to screening and/or \<45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
4. Have received live vaccine(s) within 3 months of screening, or intend to during the study.
5. Female subjects who are pregnant or nursing.
6. Exclude subjects at an increased risk for thrombosis.
7. Acute infection within one week preceding first study drug administration.
8. History of drug or alcohol abuse.
9. Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
10. Subject is on a special diet (for example subject is vegetarian).
11. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
12. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
13. Subject has a family history of severe diseases which have direct impact on the study.
14. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
15. Subject intends to be hospitalized within 3 months after first study drug administration.
16. Subjects who have donated blood or lost more than 500 mL blood within 3 months prior to the study.

Primary outcomes:
measure: Cmax
timeFrame: Up to 48 hours post dose in each treatment period
Secondary outcomes:
measure: Time of the maximum plasma concentration (Tmax)
timeFrame: Up to 48 hours post dose in each treatment period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Genuine Research Center GRC
Study officials:
affiliation: Genuine Research Center
name: Ahmed Elshafeey, Ph.D. Pharma
role: STUDY_DIRECTOR
References:
citation: Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
citation: Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
citation: Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.