A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03612557

Enrollment

Registered

2018-08-02

Start date

2018-08-20

Completion date

2018-10-02

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Benzathine benzylpenicillin, penicillin G benzathine

Brief summary

This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.

Interventions

DRUGpenicillin G benzathine

2.4 million units (IM) of benzathine benzylpenicillin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026