A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: penicillin G benzathine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03612557

B8441001

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

active treatment arm

Experimental group

Description:

penicillin G benzathine treatment

Treatment:

Drug: penicillin G benzathine