ImmunosuppressionNCT01910077
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
A study testing Tacrobell capsule 1mg and Prograf capsule 1mg in people with Immunosuppression, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Tacrobell capsule 1mg and Prograf capsule 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Nov 2013
- Phase
- Interventional
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed the informed consent from prior to screening test
- Between 19 years and 55 years in healthy male subject
- Have not any congenital or chronic disease and medical symptoms
- Body mass index(BMI) of 18 to 30 and a total body weight ≥ 55kg
- Appropriate subject for the study judging from investigator
Who cannot join
- Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
- Any condition possibly affecting drug absorption (e.g. gastrectomy)
- Subject with hypersensitivity to tacrolimus or any excipient
- Administration of cyclosporin or bosentan
- Administration of potassium-sparing diuretics
- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Show all 20Show fewer
- SBP<90 mmHg or DBP<50 mmHg, SBP>150 mmHg or DBP>100 mmHg at least 3 minutes of rest
- A positive HBsAg, HCV Ab, HIV Ab, RPR
- AST, ALT > 1.5*upper limit of normal range at the screening test
- Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test
- Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days
- Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test
- Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization
- Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization
- Continued to be drinking(alcohol> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk
- Severe heavy smoker(cigarette> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study
- Continued to be taking caffeine or can not be taken caffeine
- Continued to be taking grapefruit or can not be taken grapefruit
- Not use of contraception during the clinical study
- An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
Read the detailed description
This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.
Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.
- Conditions
- Immunosuppression
- Being tested
- Tacrobell capsule 1mg, Prograf capsule 1mg
- Keywords
- tacrolimus, tacrobell capsule, prograf capsule, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrobell capsule 1mgDrug
1 capsule, oral, over the period I\&II(crossover)
Prograf capsule 1mgDrug
1 capsule, oral, over the period I\&II(crossover)
| Study group | Role | What they receive |
|---|---|---|
| Tacrobell capsule 1mg | Experimental | Tacrolimus 1mg / 1 capsule Receives: Drug: Tacrobell capsule 1mg |
| Prograf capsule 1mg | Active comparator | Tacrolimus 1mg / 1 capsule Receives: Drug: Prograf capsule 1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
Cmax
Cmax: Maximum blood concentration
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
Secondary outcomes (4)
AUCinf
ACUinf: Area under the blood concentration-time profile from time zero extrapolated to infinite time
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
Tmax
Tmax: Time for Cmax
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
T1/2
T1/2: Terminal elimination half-life
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
CL/F
CL/F: Apparent Clearance
Measured: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong Ki Lee, MD, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910077
- Sponsor's protocol ID
- Tacrobell_BE-1301
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2013
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01910077
- Acronym / sponsor ID
- Tacrobell_BE-1301
- Conditions
- Immunosuppression
- Keywords
- tacrolimus, tacrobell capsule, prograf capsule, bioequivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Jul 2013 (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.
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
Detailed description
This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.
Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrobell capsule 1mg | Experimental | Drug: Tacrobell capsule 1mgTacrolimus 1mg / 1 capsule |
| Prograf capsule 1mg | Active comparator | Drug: Prograf capsule 1mgTacrolimus 1mg / 1 capsule |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed the informed consent from prior to screening test
- Between 19 years and 55 years in healthy male subject
- Have not any congenital or chronic disease and medical symptoms
- Body mass index(BMI) of 18 to 30 and a total body weight ≥ 55kg
- Appropriate subject for the study judging from investigator
Key exclusion criteria (20 listed)
- Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
- Any condition possibly affecting drug absorption (e.g. gastrectomy)
- Subject with hypersensitivity to tacrolimus or any excipient
- Administration of cyclosporin or bosentan
- Administration of potassium-sparing diuretics
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 capsule 1mg1 capsule, oral, over the period I\&II(crossover) | Drug | Tacrobell capsule 1mg |
| Prograf capsule 1mg1 capsule, oral, over the period I\&II(crossover) | Drug | Prograf capsule 1mg |
Primary outcome
AUClast
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration
Cmax
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
Cmax: Maximum blood concentration
4 secondary outcomes
AUCinf
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
Tmax
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
T1/2
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose
CL/F
Time frame: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours 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 23 Jul 2014.
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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.
Hyeong Ki Lee, MD, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrobell capsule 1mg and Prograf capsule 1mg in people with Immunosuppression, 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 5 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 23 Jul 2014. 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.
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: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese). 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 23 Jul 2014.