FastingPhase 1NCT01283841
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
A Phase 1 study testing Mycophenolate Mofetil in people with Fasting, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting
- 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
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2007to Dec 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.
- Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2.
- Having no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (postero-anterior view) recordings.
- Able to comply with the study procedures, in the opinion of the Principal Investigator.
- Able to give written consent for participation in the trial.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any 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 with in 14 days before dosing in Period-I. 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 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 of receiving study medicine.
- Smokers, who had a habit of smoking 10 or more than 10 cigarettes / day or could, not 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 urine drug scan.
- History of psychiatric disorders.
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of the study medicine or during the study.
- Note: In case the blood loss was ≤ 200 mL, the subject was enrolled 60 days after blood donation.
- A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies.
- A positive test result for 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 medication. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.
- Note: If the subject had participated in a study in which blood loss was ≤ 200 mL, the subject was dosed 60 days after the collection of last sample in the previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subject's participation in the study. In any such case selection of the subject will be at the discretion of the Principal Investigator/Medical Expert.
- Uric acid parameters at the time of screening are not within clinically acceptable range.
- History of gout and renal calculi.
- Sitting blood pressure less than 100/60 mm Hg at the time of screening.
- Haemoglobin less than 13 gm/dL at the time of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Balanced, Randomized, Two-treatment, Four-period, Two Sequence, Single Dose, Replicate, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence.
Read the detailed description
This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 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 three hours after dosing.
- Conditions
- Fasting
- Being tested
- Mycophenolate Mofetil
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Cellcept
Mycophenolate Mofetil 500 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Mycophenolate Mofetil 500 mg tablets of Dr. Reddy's Laboratories Limited Receives: Drug: Mycophenolate Mofetil |
| Cellcept | Active comparator | Cellcept 500 mg tablets 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.
Bioequivalence 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 posted26 Jan 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- T Gitanjali, MD, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283841
- Sponsor's protocol ID
- 291-07
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Balanced, Randomized, Two-treatment, Four-period, Two Sequence, Single Dose, Replicate, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01283841
- Acronym / sponsor ID
- 291-07
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Jan 2011 (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.
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence.
Detailed description
This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 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 three 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 500 mg tablets of Dr. Reddy's Laboratories Limited |
| Cellcept | Active comparator | Drug: Mycophenolate MofetilCellcept 500 mg tablets of Roche Laboratories Inc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.
- Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2.
- Having no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (postero-anterior view) recordings.
- Able to comply with the study procedures, in the opinion of the Principal Investigator.
- Able to give written consent for participation in the trial.
Key exclusion criteria (21 listed)
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any 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 with in 14 days before dosing in Period-I. 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 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 of 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 MofetilAlso: CellceptMycophenolate Mofetil 500 mg tablets | Drug | Cellcept, Mycophenolate Mofetil |
Primary outcome
Bioequivalence 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 26 Jan 2011.
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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.
T Gitanjali, 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 Fasting, 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 21 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 26 Jan 2011. 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?
Bioequivalence 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 26 Jan 2011.