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)

NCT05006768 | Completed Phase 1

• 1 other identifier: GRC/1/21/940
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximal measured plasma concentration

  Up to 48 hours post dose in each treatment period

Secondary Outcomes (1)

• Time of the maximum plasma concentration (Tmax)

  Up to 48 hours post dose in each treatment period

Study Arms (3)

T test

EXPERIMENTAL

Test drug (Barcimiant) 1 tablet contains 4 mg Baricitinib

Drug: Barcimiant

B reference (first dose)

ACTIVE COMPARATOR

Reference drug (Olumiant) 1 tablet contains 4 mg Baricitinib

Drug: Olumiant (first dose)

B reference (second dose)

ACTIVE COMPARATOR

Reference drug (Olumiant) 1 tablet contains 4 mg Baricitinib

Drug: Olumiant (second dose)

Interventions

Barcimiant DRUG

1 tablet contains 4 mg Barcitinib

Also known as: Olumiant

T test

Olumiant (first dose) DRUG

1 tablet contains 4 mg Barcitinib

Also known as: Olumiant

B reference (first dose)

Olumiant (second dose) DRUG

1 tablet contains 4 mg Barcitinib

Also known as: Olumiant

B reference (second dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Enrolled study participants should have normal liver function tests, blood counts, and lipid profiles at baseline prior to study drug administration.
• Clearly healthy males or females, as determined by medical history and physical examination.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
• 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.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Females should be on a suitable birth control method.
• Fully informed subjects that consented to participate in the study.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Prospective study participants who are tested and confirmed positive for latent tuberculosis before enrolling in a bioequivalence study.
• 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
• Have received live vaccine(s) within 3 months of screening, or intend to during the study.
• Female subjects who are pregnant or nursing.
• Exclude subjects at an increased risk for thrombosis.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• 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.
• Subject is on a special diet (for example subject is vegetarian).
• 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.
• 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.
• Subject has a family history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Horus Pharma: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• 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.

  PMID: 11381568 BACKGROUND

• 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.

  PMID: 2004861 BACKGROUND

• 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.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

baricitinib

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: May 5, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 24, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)