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over-encapsulated oseltamivir

Phase 1

Influenza, Human | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

over-encapsulated oseltamivir · 1 trial · 1 indication

Phase 1 1
NCT01258530A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy VolunteersInfluenza, Human
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers
Influenza, Human
NCT0125853028
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Study Endpoints

Primary Endpoints

Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))
9 days
Plasma oseltamivir carboxylate maximum observed concentration (Cmax)
9 days

Secondary Endpoints

Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC(0-t))
9 days
Plasma oseltamivir carboxylate terminal phase half-life (t1/2)
9 days
Plasma oseltamivir carboxylate time of occurrence of Cmax (tmax)
9 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALOver-encapsulated oseltamivir 75 mg (1 capsule)
Treatment BEXPERIMENTALoseltamivir 75 mg (1 capsule)

Interventions

NameTypeDescription
over-encapsulated oseltamivirDRUG75 mg once
oseltamivirDRUG75 mg once
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation...

Countries:United States
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Frequently asked questions about over-encapsulated oseltamivir

What is over-encapsulated oseltamivir used for?

Over-encapsulated oseltamivir is an investigational small molecule being developed for influenza in humans. It is a formulation of oseltamivir designed for use in clinical trials, specifically to evaluate its bioequivalence to marketed oseltamivir capsules. It is not approved and remains in clinical development.

Who makes over-encapsulated oseltamivir?

Over-encapsulated oseltamivir is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this formulation of oseltamivir for the treatment of influenza in humans.

What phase is over-encapsulated oseltamivir in?

Over-encapsulated oseltamivir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is over-encapsulated oseltamivir in?

Over-encapsulated oseltamivir has one completed clinical trial, NCT01258530, titled "A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers." This Phase 1 study enrolled 28 healthy volunteers in the United States.

Is over-encapsulated oseltamivir the same as oseltamivir?

Over-encapsulated oseltamivir is a formulation of oseltamivir, the active ingredient in marketed influenza medications. It is designed to be bioequivalent to marketed oseltamivir capsules, meaning it is intended to deliver the same drug in a form suitable for clinical trial blinding or administration.