Healthy VolunteersNCT01080443
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition
A study testing Mycophenolate Mofetil Capsule 250 mg in people with Healthy Volunteers, run by Panacea Biotec Ltd at 1 site in India.
Trial summary
The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Mycophenolate Mofetil Capsule 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2008to Jul 2008
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy human volunteers between 18 and 60 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in m2.
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12 - lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to comply with study procedures, in the opinion of the Principal Investigator.
- Able to give written consent for participation in the trial.
- In case of female subjects they must be (A) Surgically sterilized at least 6 months prior to study participation or (B) Those who are of child bearing potential must be using a suitable and effective double barrier contraceptive method or intra urine devices during the study.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any related drug.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator / Medical Expert.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or nonsteroidal anti-inflammatory drug (NSAID) induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hour prior to receiving study medicine.
- Smokers, who smoke 10 or more cigarettes per day and / or unable to abstain from smoking during the study.
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- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scan.
- History of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
- Note: In case the blood loss is ≤ 200 mL, subject may be dosed 60 days after blood donation.
- A positive hepatitis screen including hepatitis B surface antigen and anti-hepatitis C virus (HCV) antibodies.
- A positive test result for anti-HIV antibody and / or syphilis.
- The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medicine. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- Note: If subject had participated in a study in which blood loss is ≤ 200 mL, subject can be dosed 60 days after the last sample of previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medication and throughout the subject's participation in the study. In any such case subject selection will be at the discretion of the Principal Investigator / Medical Expert.
- Pregnant females or Nursing mothers
- Testing positive in urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fasting Conditions
The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.
Read the detailed description
48 +8 (stand-by) normal healthy adult 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 28 blood samples will be withdrawn for pharmacokinetic profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence, power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of the test product with that of the reference product under fasting conditions will be concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic acid.
- Conditions
- Healthy Volunteers
- Being tested
- Mycophenolate Mofetil Capsule 250 mg
- 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.
Mycophenolate Mofetil Capsule 250 mgDrug
Also called Mycophenolate Mofetil 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 |
|---|---|---|
| Cellcept® 250 mg Capsule | Active comparator | Not described Receives: Drug: Mycophenolate Mofetil Capsule 250 mg |
| Mycophenolate Mofetil Capsule 250 mg | Experimental | Not described Receives: Drug: Mycophenolate Mofetil Capsule 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the bioavailability of Mycophenolate mofetil 250 mg capsules Panacea Biotec Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA, and to assess the bioequivalence.
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 startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panacea Biotec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Pankaj K Jha, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080443
- Sponsor's protocol ID
- 328-07
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01080443
- Acronym / sponsor ID
- 328-07
- Conditions
- Healthy Volunteers
- Keywords
- Bioequivalence study in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Panacea Biotec LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (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 compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.
Detailed description
48 +8 (stand-by) normal healthy adult 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 28 blood samples will be withdrawn for pharmacokinetic profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence, power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of the test product with that of the reference product under fasting conditions will be concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic acid.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellcept® 250 mg Capsule | Active comparator | Drug: Mycophenolate Mofetil Capsule 250 mg |
| Mycophenolate Mofetil Capsule 250 mg | Experimental | Drug: Mycophenolate Mofetil Capsule 250 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal, healthy human volunteers between 18 and 60 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in m2.
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12 - lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to comply with study procedures, in the opinion of the Principal Investigator.
- Able to give written consent for participation in the trial.
Key exclusion criteria (19 listed)
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any related drug.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator / Medical Expert.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or nonsteroidal anti-inflammatory drug (NSAID) induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hour prior to receiving study medicine.
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 |
|---|---|---|
| Mycophenolate Mofetil Capsule 250 mgAlso: Mycophenolate Mofetil CapsuleSubjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule | Drug | Cellcept® 250 mg Capsule, Mycophenolate Mofetil Capsule 250 mg |
Primary outcome
To compare the bioavailability of Mycophenolate mofetil 250 mg capsules Panacea Biotec Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA, and to assess the bioequivalence.
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 12 Mar 2010.
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Screening Protocol
Pain
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. Pankaj K Jha principal investigator
Lambda Therapeutic Research 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 Mycophenolate Mofetil Capsule 250 mg 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 6 inclusion and 19 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 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 compare the bioavailability of Mycophenolate mofetil 250 mg capsules Panacea Biotec Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA, and to assess the bioequivalence. (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 12 Mar 2010.