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Tacrolimus

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 14, 2010

Target and mechanism

ModalitySmall molecule

Also known as Tacrolimus Capsules

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Tacrolimus · 2 trials · 1 indication

Phase 1 2
NCT01131988Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting ConditionsHealthy
COMPLETED40 Analytics
NCT01132027Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting ConditionsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability study based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TacrolimusEXPERIMENTALTacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited
Prograf CapsulesACTIVE_COMPARATORPrograf Capsules of Astellas Pharma US, Inc.,

Interventions

NameTypeDescription
Tacrolimus CapsulesDRUGTacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subjects should be healthy human between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter. 4. The subjects...

Countries:India
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