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erythromycin

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 22, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

erythromycin · 1 trial · 1 indication

Phase 1 1
NCT01342198An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release TabletHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
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Study Endpoints

Primary Endpoints

Area under the curve from 0 to infinity (AUCinf)
3 days
Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
3 days

Secondary Endpoints

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
3 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSingle Dose Pregabalin Controlled Release
2EXPERIMENTALSingle Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin

Interventions

NameTypeDescription
Pregabalin controlled release, 330 mgDRUGA single oral dose of 330 mg controlled release tablet
erythromycinDRUGA total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or females * Between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Illicit drug use * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable me...

Countries:Belgium
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Frequently asked questions about erythromycin

What is erythromycin used for?

Erythromycin is a small molecule being studied in healthy volunteers. It is being investigated for its effects on the pharmacokinetics of pregabalin controlled release tablets. The drug is currently in Phase 1 clinical development and is not approved for any indication.

Who makes erythromycin?

Erythromycin is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's effects in healthy volunteers.

What phase is erythromycin in?

Erythromycin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The completed Phase 1 trial involved 18 healthy participants.

What clinical trials is erythromycin in?

Erythromycin has one completed clinical trial, NCT01342198, titled "An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet." This Phase 1 study enrolled 18 healthy volunteers in Belgium.

Is erythromycin the same as pregabalin?

No, erythromycin is not the same as pregabalin. Erythromycin is the investigational drug being studied, while pregabalin is the medication whose pharmacokinetics are being examined in the clinical trial. The study investigates how erythromycin affects the absorption and processing of pregabalin controlled release tablets.