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Paricalcitol

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

Paricalcitol · 1 trial · 1 indication

Phase 1 1
NCT02322632Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting ConditionsHealthy
COMPLETED69 Analytics
PHASE1COMPLETED
Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions
HealthyUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Paricalcitol

What is Paricalcitol?

Paricalcitol is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development. The drug has been studied in a bioequivalence trial for healthy volunteers.

What is Paricalcitol used for?

Paricalcitol is being studied for use in healthy volunteers. The completed Phase 1 trial was a bioequivalence study of Paricalcitol capsules, 4 mcg, under fasting conditions. The drug's therapeutic area is classified as Other.

Who makes Paricalcitol?

Paricalcitol is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company conducted a Phase 1 clinical trial for this drug.

What phase is Paricalcitol in?

Paricalcitol is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a bioequivalence study. It is not yet approved and remains investigational.

What clinical trials is Paricalcitol in?

Paricalcitol has one completed clinical trial, NCT02322632, titled "Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions." This Phase 1 trial enrolled 69 healthy volunteers in India and was a controlled, randomized study.