HealthyPhase 1NCT02296762
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition
A Phase 1 study testing Sirolimus in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sirolimus
- 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
- Feb 2010to Feb 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent
- Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg
- Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance)
- Female Subjects
- Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Who cannot join
- Incapable of understanding the informed consent
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- Oral temperature is below 95.0°F or above 98.6°F
- Pulse rate below 50/min or above 100/min
- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs
Show all 18Show fewer
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
- Consumption of grapefruit for the past ten days prior to the check-in, in each period
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period
- Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period
- Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period
- Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing
- Clinically significant abnormalities and / or with significant diseases
- Confirmed positive in alcohol screening
- Confirmed positive in selected drug of abuse
- Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study
- Confirmed positive in urine pregnancy test
- xviii. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
India1 site
Bioserve Clinical Research Pvt. Ltd
Balanagar, Hyderabad, Andhra Pradesh, 500 037
About this study
Official title: Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Sirolimus Tablets 2 mg Under Fed Condition
This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.
Read the detailed description
Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune
Sirolimus tablets 2 mg
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus tablets 2 mg | Experimental | Sirolimus tablets 2 mg of Dr. Reddys Laboratories Limited Receives: Drug: Sirolimus |
| Rapamune | Active comparator | Rapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: predose (0.00) (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 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 Nov 2014 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Dwarakanath, MBBS, Principal investigator, Bioserve Clinical Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296762
- Sponsor's protocol ID
- P-636/08
- Status last verified
- Mar 2010
- First submitted
- 18 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Sirolimus Tablets 2 mg Under Fed Condition
- ClinicalTrials.gov ID
- NCT02296762
- Acronym / sponsor ID
- P-636/08
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Nov 2014 (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.
This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.
Detailed description
Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus tablets 2 mg | Experimental | Drug: SirolimusSirolimus tablets 2 mg of Dr. Reddys Laboratories Limited |
| Rapamune | Active comparator | Drug: SirolimusRapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide written informed consent
- Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg
- Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance)
- Female Subjects
Key exclusion criteria (18 listed)
- Incapable of understanding the informed consent
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- Oral temperature is below 95.0°F or above 98.6°F
- Pulse rate below 50/min or above 100/min
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 |
|---|---|---|
| SirolimusAlso: RapamuneSirolimus tablets 2 mg | Drug | Rapamune, Sirolimus tablets 2 mg |
Primary outcome
Area under curve (AUC)
Time frame: predose (0.00) (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 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 Nov 2014.
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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. Dwarakanath, MBBS principal investigator
Bioserve 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 Sirolimus 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 7 inclusion and 18 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 Nov 2014. 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: predose (0.00) (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 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 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.