Healthy VolunteersPhase 1NCT04114461
Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
A Phase 1 study testing HL-TOF tab. 5mg and Xeljanz tab. 5mg in people with Healthy Volunteers, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HL-TOF tab. 5mg and Xeljanz tab. 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2019to 4 Dec 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Years 19-60
- No pathological symptoms or findings
- Suitable for the criteria for examination
- 90≤SBP≤139, 60≤DBP≤89
- Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
- Contraceptive during the study period
- Volunteer for the study and sign to ICF
Who cannot join
- Subject with medical history which affect on the absorption of drug
- Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC< 500cells/mm3, ALC<500cells/mm3, Hb<8g/dL
- Subject with hypersensitivity reaction to HL-TOF and Xeljanz
- Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subject who take a vaccination within 30 days
- Subject who take a medication such as barbiturates within 30 days
Show all 12Show fewer
- Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
- Subject who take alcohol more than 21 cups per week
- Subject who smoke 20 cigarettes per day
- Subject who participate in any clinical investigation within 6 month prior to study medication dosing
- Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
- Subject with decision of non-participation through investigator's review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of HL-TOF Tab. 5 mg Compared With Those of XelJanz Tab. in Healthy Volunteers
To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers
Read the detailed description
The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.
- Conditions
- Healthy Volunteers
- Being tested
- HL-TOF tab. 5mg, Xeljanz tab. 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-TOF tab. 5mgDrug
Also called Tofacitinib freebase
HL-TOF
Xeljanz tab. 5mgDrug
Also called Tofacitinib citrate
Xeljanz
| Study group | Role | What they receive |
|---|---|---|
| HL-TOF tab. 5mg | Experimental | Tofacitinib freebase Receives: Drug: HL-TOF tab. 5mg |
| Xeljanz tab. 5mg | Active comparator | Tofacitinib citrate (5mg as tofacitinib) Receives: Drug: Xeljanz tab. 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration
Measured: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
AUC
Area under curve
Measured: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Secondary outcomes (1)
AE
Number of participants with adverse events
Measured: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start6 Nov 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2X2
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JAEWOO KIM, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114461
- Sponsor's protocol ID
- HL-TOF-101
- Status last verified
- May 2020
- First submitted
- 2 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of HL-TOF Tab. 5 mg Compared With Those of XelJanz Tab. in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04114461
- Acronym / sponsor ID
- HL-TOF-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 3 Oct 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.
To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers
Detailed description
The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2X2
| Arm | Type | Receives |
|---|---|---|
| HL-TOF tab. 5mg | Experimental | Drug: HL-TOF tab. 5mgTofacitinib freebase |
| Xeljanz tab. 5mg | Active comparator | Drug: Xeljanz tab. 5mgTofacitinib citrate (5mg as tofacitinib) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Years 19-60
- No pathological symptoms or findings
- Suitable for the criteria for examination
- 90≤SBP≤139, 60≤DBP≤89
- Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
Key exclusion criteria (12 listed)
- Subject with medical history which affect on the absorption of drug
- Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC< 500cells/mm3, ALC<500cells/mm3, Hb<8g/dL
- Subject with hypersensitivity reaction to HL-TOF and Xeljanz
- Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subject who take a vaccination within 30 days
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 |
|---|---|---|
| HL-TOF tab. 5mgAlso: Tofacitinib freebaseHL-TOF | Drug | HL-TOF tab. 5mg |
| Xeljanz tab. 5mgAlso: Tofacitinib citrateXeljanz | Drug | Xeljanz tab. 5mg |
Primary outcome
Cmax
Time frame: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Maximum concentration
AUC
Time frame: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Area under curve
1 secondary outcome
AE
Time frame: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
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 12 May 2020.
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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.
JAEWOO KIM principal investigator
H Plus Yangji Hospital
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 HL-TOF tab. 5mg and Xeljanz tab. 5mg in people with Healthy Volunteers, run by Hanlim Pharm. Co., Ltd. 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 7 inclusion and 12 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 12 May 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?
Cmax (time frame: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour). 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 12 May 2020.