HealthyPhase 1NCT01513044
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting 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… Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 68 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Jan 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged between 18 and 50 years (including both).
- Subjects' weight within the normal range according to normal values for the Body
- Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PIA view).
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- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Subjects having negative alcohol breath test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
Who cannot join
- The subjects were excluded from the study, if they meet any of the following criteria:
- Hypersensitivity to Mycophenolate Mofetil or related drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
- History or presence of asthma, urticaria or other significant allergic reactions.
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- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
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 Fasting 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 fasting 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 Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 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 completionJan 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinesh Shah, MD, Principal investigator, veeda clinical research Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513044
- Sponsor's protocol ID
- 08-VIN-182
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01513044
- Acronym / sponsor ID
- 08-VIN-182
- Conditions
- Healthy
- Keywords
- bioequivalence, Mycophenolate Mofetil, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 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 fasting 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 Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 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 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects aged between 18 and 50 years (including both).
- Subjects' weight within the normal range according to normal values for the Body
- Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
Key exclusion criteria (19 listed)
- Hypersensitivity to Mycophenolate Mofetil or related drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
- History or presence of asthma, urticaria or other significant allergic reactions.
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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 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.
Jinesh Shah, MD principal investigator
veeda clinical research Pvt. 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 9 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 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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 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.