A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2018-10-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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active treatment arm

penicillin G benzathine treatment

Group Type EXPERIMENTAL

penicillin G benzathine

Intervention Type DRUG

2.4 million units (IM) of benzathine benzylpenicillin

Interventions

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penicillin G benzathine

2.4 million units (IM) of benzathine benzylpenicillin

Intervention Type DRUG

Other Intervention Names

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penicillin G benzathine benzylpenicillin

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes