A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

• Status: Completed
• Trial end date: 2018-10-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

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).