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DFN-15 Dose 1

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 13, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

DFN-15 Dose 1 · 1 trial · 1 indication

Phase 1 1
NCT03051685Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy AdultsHealthy
COMPLETED16 Analytics
PHASE1COMPLETED
Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults
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Study Endpoints

Primary Endpoints

Pharmacokinetic (PK) parameters of DFN-15
Up to 72 hours

DFN-15 maximum Plasma Concentration (Cmax)

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
DFN-15 Dose 1EXPERIMENTAL -
DFN-15 Dose 2EXPERIMENTAL -
DFN-15 Dose 3EXPERIMENTAL -
Active ComparatorACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DFN-15 Dose 1DRUG -
DFN-15 Dose 2DRUG -
DFN-15 Dose 3DRUG -
Active ComparatorDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects were male or female, at least 18 years of age but not older than 45 years of age. The main inclusion criteria were: 1. non- or ex-smokers 2. body mass index (BMI) ≥18.50 kg/m2 and \<30.00 kg/m2 3. no clinically significant abnormality found in the 12-lead ECG performed...

Countries:United States
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Frequently asked questions about DFN-15 Dose 1

What is DFN-15 Dose 1?

DFN-15 Dose 1 is an investigational small molecule being developed by Dr. Reddy's Laboratories Ltd (RDY). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied to assess its bioavailability and dose proportionality.

What is DFN-15 Dose 1 used for?

DFN-15 Dose 1 is being studied for use in healthy volunteers. The Phase 1 trial is designed to evaluate the bioavailability of DFN-15 at different doses and to determine dose proportionality in fasting healthy adults. It is not yet approved for any medical condition.

Who makes DFN-15 Dose 1?

DFN-15 Dose 1 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's pharmacokinetic properties in healthy subjects.

What phase is DFN-15 Dose 1 in?

DFN-15 Dose 1 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in a completed Phase 1 trial that enrolled 16 healthy adult participants in the United States.

What clinical trials is DFN-15 Dose 1 in?

DFN-15 Dose 1 has one completed clinical trial, registered under NCT03051685. The study, titled 'Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults,' was a Phase 1 trial conducted in the United States with 16 healthy participants.

Is DFN-15 Dose 1 the same as DFN-15?

DFN-15 Dose 1 is a specific dose level of the investigational drug DFN-15. The clinical trial NCT03051685 evaluates DFN-15 at three different doses, including Dose 1, to compare bioavailability against a comparator and assess dose proportionality in healthy adults.