HealthyPhase 1NCT01513057
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed Conditions
A Phase 1 study testing Mycophenolate Mofetil in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Feb 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, human male volunteers between 18 - 55 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 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest recordings.
- Able to comply with the study procedures, in the opinion of the Principal investigator.
- Able to give voluntary written informed consent for participation in the study.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate mofetil or any related drug.
- Any disease or condition that compromised the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection was at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of alcoholism (< 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hours prior to receiving study medicine.
- Smokers, who smoked 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
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- Consumption of Grapefruits or its products within a period of 48 hours prior to dosing.
- 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 scans.
- History of psychiatric disorders.
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) or 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 was taken into consideration for inclusion of the subject in the study.
- Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject could be enrolled 60 days after the last sample of previous study.
- A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
- A positive test result for HIV antibody and/or syphilis.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subjects' participation in the study. In any such case subject selection was at the discretion of the Principal Investigator.
- All the enrolled subjects satisfied all the above inclusion and exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fed Conditions.
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.
Read the detailed description
This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under fed conditions.64 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first two hours after dosing.
- Conditions
- Healthy
- Being tested
- Mycophenolate Mofetil
- Keywords
- bioequivalence, Mycophenolate Mofetil, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
Also called Cellcept
250 mg capsules of Roche Laboratories Inc.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited Receives: Drug: Mycophenolate Mofetil |
| Cellcept | Active comparator | Cellcept 250 mg capsules of Roche Laboratories Inc. Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionFeb 2009
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pankaj Kumar Jha, MD, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513057
- Sponsor's protocol ID
- 466-08
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01513057
- Acronym / sponsor ID
- 466-08
- Conditions
- Healthy
- Keywords
- bioequivalence, Mycophenolate Mofetil, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Jan 2012 (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.
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.
Detailed description
This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under fed conditions.64 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first two hours after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Drug: Mycophenolate MofetilMycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited |
| Cellcept | Active comparator | Drug: Mycophenolate MofetilCellcept 250 mg capsules of Roche Laboratories Inc. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, human male volunteers between 18 - 55 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 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest recordings.
- Able to comply with the study procedures, in the opinion of the Principal investigator.
- Able to give voluntary written informed consent for participation in the study.
Key exclusion criteria (17 listed)
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate mofetil or any related drug.
- Any disease or condition that compromised the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection was at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of alcoholism (< 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hours 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 MofetilMycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited | Drug | Mycophenolate Mofetil |
| Mycophenolate MofetilAlso: Cellcept250 mg capsules of Roche Laboratories Inc. | Drug | Cellcept |
Primary outcome
Area Under Curve (AUC)
Time frame: pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose
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 20 Jan 2012.
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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.
Pankaj Kumar Jha, MD 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 Phase 1 study testing Mycophenolate Mofetil 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 5 inclusion and 17 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 20 Jan 2012. 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?
Area Under Curve (AUC) (time frame: pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose). 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 20 Jan 2012.