Immunosuppressant(Organ Transplantation, RA)Phase 1NCT02336854
Tacrobell tab_Phase1_PK
A Phase 1 study testing Tacrobell tab. 2mg and Prograf cap. 2mg in people with Immunosuppressant(Organ Transplantation, RA), run by Chong Kun Dang Pharmaceutical.
Trial summary
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immunosuppressant(Organ Transplantation, RA)
- What is being tested?
- Tacrobell tab. 2mg and Prograf cap. 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2015to 19 Mar 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the requirements of the study and voluntarily consent to participate in the study.
- Healthy male volunteer in the age between 20 and 45 years old.
- Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2
Who cannot join
- presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug, or major surgery of the gastrointestinal tract except for appendectomy
- any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation)
- administration of cyclosporine or Bosentan
- administration of potassium sparing diuretic
- Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Show all 20Show fewer
- SBP > 150 mmHg or< 90 mmHg
- DBP > 100 mmHg or < 50 mmHg
- positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR
- AST or ALT > 1.5*ULN, e-GFR < 80 mL/min
- history of drug abuse or positive drug screening test
- intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations
- medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing
- administration of another study medications within 3 months before first dosing
- blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing
- Alcohol > 21 units/week or cannot stop drinking during the study
- Cigarette > 10 cigarettes/day or cannot stop smoking during hospitalization
- consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization
- consumption of grapefruit or food containing grapefruit during hospitalization
- Not eligible to participate for the study at the discretion of investigator.
About this study
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
- Being tested
- Tacrobell tab. 2mg, Prograf cap. 2mg
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrobell tab. 2mgDrug
Prograf cap. 2mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Tacrobell tab. 2mg | Experimental | 2mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover) Receives: Drug: Tacrobell tab. 2mg |
| Prograf cap. 2mg | Active comparator | 1mg/capsule, PO, 2 capsule once daily for Period I \& II D1(crossover) Receives: Drug: Prograf cap. 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: up to 96 hous postdose
Cmax
Measured: up to 96 hous postdose
Secondary outcomes (4)
AUCinf
Measured: up to 96 hous postdose
Tmax
Measured: up to 96 hous postdose
t1/2
Measured: up to 96 hous postdose
CL/F
Measured: up to 96 hous postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start12 Jan 2015
- Primary completion2 Feb 2015
- Study completion19 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunosuppressant(Organ Transplantation, RA)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT02336854
- Sponsor's protocol ID
- 111HPS14027
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrobell tab_Phase1_PK
- ClinicalTrials.gov ID
- NCT02336854
- Acronym / sponsor ID
- 111HPS14027
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 2 Feb 2015 (actual)
- Study completion
- 19 Mar 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrobell tab. 2mg | Experimental | Drug: Tacrobell tab. 2mg2mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover) |
| Prograf cap. 2mg | Active comparator | Drug: Prograf cap. 2mg1mg/capsule, PO, 2 capsule once daily for Period I \& II D1(crossover) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Understand the requirements of the study and voluntarily consent to participate in the study.
- Healthy male volunteer in the age between 20 and 45 years old.
- Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2
Key exclusion criteria (20 listed)
- presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug, or major surgery of the gastrointestinal tract except for appendectomy
- any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation)
- administration of cyclosporine or Bosentan
- administration of potassium sparing diuretic
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 |
|---|---|---|
| Tacrobell tab. 2mg | Drug | Tacrobell tab. 2mg |
| Prograf cap. 2mg | Drug | Prograf cap. 2mg |
Primary outcome
AUClast
Time frame: up to 96 hous postdose
Cmax
Time frame: up to 96 hous postdose
4 secondary outcomes
AUCinf
Time frame: up to 96 hous postdose
Tmax
Time frame: up to 96 hous postdose
t1/2
Time frame: up to 96 hous postdose
CL/F
Time frame: up to 96 hous postdose
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 8 Aug 2017.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tacrobell tab. 2mg and Prograf cap. 2mg in people with Immunosuppressant(Organ Transplantation, RA), run by Chong Kun Dang Pharmaceutical.
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 3 inclusion and 20 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
AUClast (time frame: up to 96 hous postdose). 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 8 Aug 2017.