Rheumatoid ArthritisPhase 1NCT03868072
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
A Phase 1 study testing XELJANZ 5Mg Tablet and Chong Kun Dang Tofacitinib Tablet in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- XELJANZ 5Mg Tablet and Chong Kun Dang Tofacitinib Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2019to 20 Apr 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject older than 19 years at the screening
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
- Women who are not pregnant at physical examination
Who cannot join
- Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the 1 month
- Individuals who had taken any medication within 10 days prior to the first day of dosing
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
- Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
- Individuals who donated whole blood within the 2 months, or blood components within 2 weeks prior to the first dose of the investigational product(s)
- Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days (only, 4 weeks for women who may be pregnant) after investigational product(s) administration (Double contraception: two or more of the use of condoms, intrauterine contraception, diaphragm, cervical cap, or a sexual partner who had been medically diagnosed infertility)
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- Individuals with hypersensitivity to ingredients used in the investigational product(s)
- Patients with serious infection (e.g., Sepsis) or active infection including localized infection
- Patients with active tuberculosis
- Patients with severe hepatopathy
- Patients with an absolute neutrophil count (ANC) less than 500 cells/mm3
- Patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3
- Patients who have hemoglobin levels less than 8 g/dL
- Women who are pregnant or may be pregnant or lactating
- Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Patients with nephropathy (BUN<8 or BUN>20 or Creatinine>1.5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers
Read the detailed description
To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.
Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Rheumatoid Arthritis
- Being tested
- XELJANZ 5Mg Tablet, Chong Kun Dang Tofacitinib Tablet
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELJANZ 5Mg TabletDrug
XELJANZ 5Mg Tablet 1T single oral administration under fasting
Chong Kun Dang Tofacitinib TabletDrug
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
| Study group | Role | What they receive |
|---|---|---|
| Reference/Test | Experimental | 1. Period 1: XELJANZ 5Mg Tablet 1T
2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T Receives: Drug: XELJANZ 5Mg Tablet; Drug: Chong Kun Dang Tofacitinib Tablet |
| Test/Reference | Experimental | 1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T
2. Period 2: XELJANZ 5Mg Tablet 1T Receives: Drug: XELJANZ 5Mg Tablet; Drug: Chong Kun Dang Tofacitinib Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start22 Feb 2019
- Primary completion29 Mar 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868072
- Sponsor's protocol ID
- BE118111814 / BN1-18-118
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03868072
- Acronym / sponsor ID
- BE118111814 / BN1-18-118
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers
Detailed description
To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.
Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference/Test | Experimental | Drug: XELJANZ 5Mg Tablet, Drug: Chong Kun Dang Tofacitinib Tablet1. Period 1: XELJANZ 5Mg Tablet 1T 2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T |
| Test/Reference | Experimental | Drug: XELJANZ 5Mg Tablet, Drug: Chong Kun Dang Tofacitinib Tablet1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T 2. Period 2: XELJANZ 5Mg Tablet 1T |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subject older than 19 years at the screening
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
- Women who are not pregnant at physical examination
Key exclusion criteria (16 listed)
- Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the 1 month
- Individuals who had taken any medication within 10 days prior to the first day of dosing
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
- Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
- Individuals who donated whole blood within the 2 months, or blood components within 2 weeks prior to the first dose of the investigational product(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XELJANZ 5Mg TabletXELJANZ 5Mg Tablet 1T single oral administration under fasting | Drug | Reference/Test, Test/Reference |
| Chong Kun Dang Tofacitinib TabletChong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting | Drug | Reference/Test, Test/Reference |
Primary outcome
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Time frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Time frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XELJANZ 5Mg Tablet and Chong Kun Dang Tofacitinib Tablet in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 6 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 30 Jan 2020. 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 South Korea. 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?
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet (time frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2020.