HealthyPhase 1NCT01132027
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions
A Phase 1 study testing Tacrolimus Capsules in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tacrolimus Capsules
- 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 siteIndia
- Study dates
- Jan 2008to Mar 2008
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects should be healthy human between 18 and 45 years.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
- The subjects should be able to communicate effectively with study personnel.
- The subjects should be able to give written informed consent to participate in the study.
- If subject is a female volunteer and
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- Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms,foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- Is postmenopausal for at least 1 year.
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Who cannot join
- The subjects who have a history of allergic responses to tacrolimus or other related drugs.
- The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
- The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- The subjects who have a history or presence of bronchial asthma.
- The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
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- The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
- The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
- The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
- The subjects who have a positive hepatitis screen (include subtypes A, B, C and E).
- The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication application.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast-feeding.
- Female volunteers not willing to use contraception during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Two Way Crossover, Balanced, Single Dose, Comparative Evaluation of Relative Bioavailability of Tacrolimus Capsules 5 mg With That of 'Prograf' Capsules 5 mg in Healthy Subjects Under Non-fasting Conditions.
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects.
Read the detailed description
An open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg with that of 'prograf' capsules 5 mg in healthy adult human subjects under non-fasting conditions.
- Conditions
- Healthy
- Being tested
- Tacrolimus Capsules
- Keywords
- Bioavailability, crossover, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus CapsulesDrug
Also called Prograf capsules of Astellas Pharma US, Inc.,
Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited Receives: Drug: Tacrolimus Capsules |
| Prograf Capsules | Active comparator | Prograf Capsules of Astellas Pharma US, Inc., Receives: Drug: Tacrolimus Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability study based on Cmax and AUC parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Simran Sethi, MBBS, Principal investigator, BA Research India Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132027
- Sponsor's protocol ID
- BA0859003
- Status last verified
- Jun 2010
- First submitted
- 26 May 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Two Way Crossover, Balanced, Single Dose, Comparative Evaluation of Relative Bioavailability of Tacrolimus Capsules 5 mg With That of 'Prograf' Capsules 5 mg in Healthy Subjects Under Non-fasting Conditions.
- ClinicalTrials.gov ID
- NCT01132027
- Acronym / sponsor ID
- BA0859003
- Conditions
- Healthy
- Keywords
- Bioavailability, crossover, tacrolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 27 May 2010 (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 compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects.
Detailed description
An open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg with that of 'prograf' capsules 5 mg in healthy adult human subjects under non-fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: Tacrolimus CapsulesTacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited |
| Prograf Capsules | Active comparator | Drug: Tacrolimus CapsulesPrograf Capsules of Astellas Pharma US, Inc., |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subjects should be healthy human between 18 and 45 years.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
- The subjects should be able to communicate effectively with study personnel.
- The subjects should be able to give written informed consent to participate in the study.
Key exclusion criteria (15 listed)
- The subjects who have a history of allergic responses to tacrolimus or other related drugs.
- The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
- The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- The subjects who have a history or presence of bronchial asthma.
- The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
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 |
|---|---|---|
| Tacrolimus CapsulesAlso: Prograf capsules of Astellas Pharma US, Inc.,Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited | Drug | Prograf Capsules, Tacrolimus |
Primary outcome
Bioavailability study based on Cmax and AUC parameters
Time frame: 3 months
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 14 Jun 2010.
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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.
Dr. Simran Sethi, MBBS principal investigator
BA Research India Limited
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 Tacrolimus Capsules in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 9 inclusion and 15 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 14 Jun 2010. 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 India. 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?
Bioavailability study based on Cmax and AUC parameters (time frame: 3 months). 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 14 Jun 2010.