A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Pfizer8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

penicillin G benzathineDRUG

2.4 million units (IM) of benzathine benzylpenicillin

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, Japan