Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment arm | Experimental | penicillin G benzathine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| penicillin G benzathine | Drug | 2.4 million units (IM) of benzathine benzylpenicillin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects experiencing an Adverse Event | Screening up to 28 days after last dose of study medication |
Not provided
Inclusion Criteria:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-one Clinic, Keikokai Medical Corporation | Hachioji-shi | Tokyo | 192-0071 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010401 | Penicillin G Benzathine |
| D010400 | Penicillin G |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |