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Test product

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: May 31, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Test product · 1 trial · 1 indication

Phase 1 1
NCT01632449Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.Healthy Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
Healthy Volunteers
NCT0163244980
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Study Endpoints

Primary Endpoints

PK - Area under the plasma concentration curve.
Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Peak plasma concentration as a measure of PK.
Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours

Secondary Endpoints

The number of AEs in participants as a measure of safety and tolerability.
Participants will be followed during the study, 4 days.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTest product
2EXPERIMENTALReference product

Interventions

NameTypeDescription
Test productDRUGDimethyl Fumarate (BG00012)
Reference productDRUGDimethyl Fumarate (BG00012)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must give written and informed consent and any authorizations required by local law. * Males and females 18 - 55 years old inclusive at time of consent. * Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: * History of malignancy (...

Countries:United States
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Frequently asked questions about Test product

What is Test product used for?

Test product is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its bioequivalence. The drug is not approved and remains under investigation for its intended use.

Who makes Test product?

Test product is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational small molecule in healthy volunteer populations.

What phase is Test product in?

Test product is in Phase 1 clinical development. A single Phase 1 trial has been completed, which enrolled 80 healthy volunteers in the United States. The drug remains investigational and has not received regulatory approval.

What clinical trials is Test product in?

Test product has one completed clinical trial registered as NCT01632449, titled 'Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.' This Phase 1 study enrolled 80 healthy volunteers in the United States and was a controlled, randomized trial.

Is Test product FDA approved?

Test product is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers was designed to assess bioequivalence, but the drug has not yet received marketing authorization from regulatory authorities.