Healthy VolunteersNCT01080482
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition
A study testing Tacrolimus 5 mg Capsule in people with Healthy Volunteers, run by Panacea Biotec Ltd at 1 site in India.
Trial summary
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tacrolimus 5 mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2007to Oct 2007
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects in the range of age from 18 to 55 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with normal findings as determined by Haemogram with ESR, Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and Urinalysis, ECG, X-ray (X-ray if taken).
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
- Agreeing to, not using any medication prescription and over the counter medications including vitamins and minerals for 14 days prior to study \& during the course of the study.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- Non-smokers, ex smokers and moderate smokers will be included. "Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who completely stopped smoking for at least 3 months."
Who cannot join
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day 1 of dosing.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History or presence of malignancy or other serious diseases.
- Refusal to abstain from food for at least ten (10) hours prior to administration of the study drug and for four (4) additional hours each, post dose during each study period.
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- Any contraindication to blood sampling.
- Refusal to abstain from water for at least one (1) hour prior to study drug administration on dosing day of each study period and for at least two (2) additional hours, post dosing except 240 mL administered during administration of the dose.
- Use of xanthine-containing beverages or food and grapefruit or grapefruit products for 48 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- Subjects having contradiction or hypersensitivity to Tacrolimus or related group of drugs or any excipients of the products.
- Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period.
- Found positive in Breath alcohol test done at the time of screening or on the day of enrollment for each study period or for every ambulatory sample.
- History or presence of problem in swallowing tablets or capsules.
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Laboratories (I) Pvt. Ltd.
Navi Mumbai, Maharashtra, 400 709
About this study
Official title: A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 5 mg in Normal Healthy Male Subjects Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.
Read the detailed description
Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 23 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Tacrolimus will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
- Conditions
- Healthy Volunteers
- Being tested
- Tacrolimus 5 mg Capsule
- Keywords
- Bioequivalence study in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 5 mg CapsuleDrug
Also called Tacrolimus Capsule
Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
| Study group | Role | What they receive |
|---|---|---|
| Prograf® Capsule 5 mg | Active comparator | Not described Receives: Drug: Tacrolimus 5 mg Capsule |
| Tacrolimus Capsule 5 mg | Experimental | Not described Receives: Drug: Tacrolimus 5 mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg manufactured by Astellas Pharma, Inc., USA
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionOct 2007
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panacea Biotec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Suhas Khandave, Principal investigator, Accutest Research Laboratories (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080482
- Sponsor's protocol ID
- US/07/054
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 5 mg in Normal Healthy Male Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT01080482
- Acronym / sponsor ID
- US/07/054
- Conditions
- Healthy Volunteers
- Keywords
- Bioequivalence study in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Panacea Biotec LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Mar 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 objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.
Detailed description
Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 23 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Tacrolimus will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf® Capsule 5 mg | Active comparator | Drug: Tacrolimus 5 mg Capsule |
| Tacrolimus Capsule 5 mg | Experimental | Drug: Tacrolimus 5 mg Capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects in the range of age from 18 to 55 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with normal findings as determined by Haemogram with ESR, Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and Urinalysis, ECG, X-ray (X-ray if taken).
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
Key exclusion criteria (15 listed)
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day 1 of dosing.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History or presence of malignancy or other serious diseases.
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 5 mg CapsuleAlso: Tacrolimus CapsuleSubjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule | Drug | Prograf® Capsule 5 mg, Tacrolimus Capsule 5 mg |
Primary outcome
To demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg manufactured by Astellas Pharma, Inc., USA
Time frame: up to 3 days
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 4 Mar 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. Suhas Khandave principal investigator
Accutest Research Laboratories (I) Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus 5 mg Capsule in people with Healthy Volunteers, run by Panacea Biotec Ltd 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 8 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 4 Mar 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.
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?
To demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg manufactured by Astellas Pharma, Inc., USA (time frame: up to 3 days). 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 4 Mar 2010.