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Sirolimus

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Nov 20, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Sirolimus · 2 trials · 1 indication

Phase 1 2
NCT02296762Bioavailability Study of Sirolimus Tablets 2 mg Under Fed ConditionHealthy
COMPLETED36 Analytics
NCT02296749Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting ConditionHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition
Healthy
NCT0229676236
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PHASE1COMPLETED
Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting Condition
Healthy
NCT0229674960
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Study Endpoints

Primary Endpoints

Area under curve (AUC)
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sirolimus tablets 2 mgEXPERIMENTALSirolimus tablets 2 mg of Dr. Reddys Laboratories Limited
RapamuneACTIVE_COMPARATORRapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia

Interventions

NameTypeDescription
SirolimusDRUGSirolimus tablets 2 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: i. Provide written informed consent ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg iii. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 iv. Must be of nor...

Countries:India
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