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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03718611 |
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Date of registration:
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23/10/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
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Scientific title:
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A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects |
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Date of first enrolment:
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October 22, 2018 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03718611 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Young-Ran Yoon, M.D. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyungpook National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults 19-50 years of age
- Body mass index (BMI) = 18.5 and = 27.0 kg/m^2 at screening
- Medically healthy with no clinically significant medical history
- No clinically significant result with laboratory test including chemistry, serum,
urine test within 3 weeks in prior to administration of investigational product
- Understands the study procedures in the Informed consent form (ICF), and be willing
and able to comply with the protocol
Exclusion Criteria:
- History or presence of clinically significant medical or psychiatric condition or
disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg) or hepatitis C virus (HCV).
- Creatinint clearance < 80 mL/min (using Cockcroft-Gault) at screening.
- Whole blood donation within a 2 months prior to the first dose of study drug.
- Participation in another clinical trial or bioequivalence study within 12 weeks prior
to the first dose of study drug(s).
Age minimum:
19 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: BR9001
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Drug: BR900A
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Primary Outcome(s)
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Cmax
[Time Frame: 0-24 hours after administration]
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AUClast
[Time Frame: 0-24 hours after administration]
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Secondary ID(s)
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BR-TFD-CT-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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