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Abacavir/Lamivudine

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 4, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Abacavir/Lamivudine · 1 trial · 1 indication

Phase 1 1
NCT01220232Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy SubjectsHealthy Volunteers
COMPLETED14 Analytics
PHASE1COMPLETED
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
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Study Endpoints

Primary Endpoints

To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
17 days

Secondary Endpoints

To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.
17 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Abacavir/LamivudineACTIVE_COMPARATOR -
Lersivirine + Abacavir/LamivudineEXPERIMENTAL -

Interventions

NameTypeDescription
Abacavir/LamivudineDRUGAbacavir/Lamivudine 600/300 mg QD for 5 days
LersivirineDRUGLersivirine 750 mg QD for 10 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. * Total body weight \>50 kg (110 lbs). Exclusion Criteria: * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL...

Countries:United States
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Frequently asked questions about Abacavir/Lamivudine

What is Abacavir/Lamivudine used for?

Abacavir/Lamivudine is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being investigated for its potential effects in healthy subjects, as part of early-stage research.

Who makes Abacavir/Lamivudine?

Abacavir/Lamivudine is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting early-stage clinical research on this drug in healthy volunteers.

What phase is Abacavir/Lamivudine in?

Abacavir/Lamivudine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers as part of early-stage research.

What clinical trials is Abacavir/Lamivudine in?

Abacavir/Lamivudine has one completed clinical trial, NCT01220232, titled "Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects." This Phase 1 study enrolled 14 participants in the United States and was an active-controlled trial.

Is Abacavir/Lamivudine the same as Lersivirine?

No, Abacavir/Lamivudine is not the same as Lersivirine. In the clinical trial NCT01220232, Lersivirine was studied for its effect on the pharmacokinetics of Abacavir/Lamivudine. Abacavir/Lamivudine is a combination drug being investigated in healthy volunteers.