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penicillin G benzathine

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 10, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

penicillin G benzathine · 1 trial · 1 indication

Phase 1 1
NCT03612557A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy SubjectsHealthy
COMPLETED8 Analytics
PHASE1COMPLETED
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
Healthy
NCT036125578
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration for penicillin G (Cmax)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Time to Cmax (Tmax)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent clearance (as data permit) (CL/F)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent volume of distribution (as data permit) (Vz/F)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Terminal half life (as data permit) (t1/2)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

Secondary Endpoints

Number of Subjects experiencing an Adverse Event
Screening up to 28 days after last dose of study medication
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
active treatment armEXPERIMENTALpenicillin G benzathine treatment

Interventions

NameTypeDescription
penicillin G benzathineDRUG2.4 million units (IM) of benzathine benzylpenicillin
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg and \<100 kg. Exclusion Criteria: • Evidence or history of clinically significant hematological, renal, ...

Countries:Japan
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