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HealthyPhase 1NCT05006768

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)

A Phase 1 study testing Barcimiant, Olumiant (first dose) and Olumiant (second dose) in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Barcimiant, Olumiant (first dose) and Olumiant (second dose)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
5 May 2021to 24 Jun 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • Subjects who have donated blood or lost more than 500 mL blood within 3 months prior to the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Genuine Research Center GRC

    Cairo, 11757

Other trials in Egypt

About this study

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)

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)

Read the 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.

Conditions
Healthy
Being tested
Barcimiant, Olumiant (first dose), Olumiant (second dose)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BarcimiantDrug

    Also called Olumiant

    1 tablet contains 4 mg Barcitinib

  • Olumiant (first dose)Drug

    Also called Olumiant

    1 tablet contains 4 mg Barcitinib

  • Olumiant (second dose)Drug

    Also called Olumiant

    1 tablet contains 4 mg Barcitinib

Study groups in NCT05006768
Study groupRoleWhat they receive
T testExperimentalTest drug (Barcimiant) 1 tablet contains 4 mg Baricitinib
Receives: Drug: Barcimiant
B reference (first dose)Active comparatorReference drug (Olumiant) 1 tablet contains 4 mg Baricitinib
Receives: Drug: Olumiant (first dose)
B reference (second dose)Active comparatorReference drug (Olumiant) 1 tablet contains 4 mg Baricitinib
Receives: Drug: Olumiant (second dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximal measured plasma concentration

    Measured: Up to 48 hours post dose in each treatment period

Secondary outcomes (1)

  1. Time of the maximum plasma concentration (Tmax)

    The amount of time that a drug is present at the maximum concentration in serum

    Measured: Up to 48 hours post dose in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start5 May 2021
  3. Primary completion3 Jun 2021
  4. Study completion24 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05006768
Sponsor's protocol ID
GRC/1/21/940
Status last verified
Aug 2021
First submitted
9 Aug 2021
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11381568

  • 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.

    PubMed 2004861

  • 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.

    PubMed 3450848

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Barcimiant, Olumiant (first dose) and Olumiant (second dose) in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Up to 48 hours post dose in each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05006768, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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