Recent Updates
Recently added Catalysts

Paricalcitol ,

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Dec 23, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02322632Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting ConditionsPHASE1 COMPLETED 69 — — Nov 1, 2010Feb 1, 2011Dec 23, 20141 India
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under curve
0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0 and 60.0 hours post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Paricalcitol Capsules, 4 mcgEXPERIMENTALParicalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited
Zemplar Capsules, 4 mcgEXPERIMENTALZemplar Capsules, 4 mcg of Abott Laboratories USA
Interventions
NameTypeDescription
Paricalcitol Capsules, 4 mcgDRUGParicalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, adult, human volunteers between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India. * Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2. * Have no significan...

Countries:India
Unlock Eligibility Criteria