---
title: Ceftaroline China Pharmacokinetics Study
nct_id: NCT01458743
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01458743.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01458743"
ct_last_update_post_date: 2017-09-05
last_seen_at: "2026-05-12T07:34:19.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ceftaroline China Pharmacokinetics Study

**Official Title:** A Phase I, Single Center, Open Label, Two Groups Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 Hours and as 120-minute Intravenous Infusion Every 8 Hours

**NCT ID:** [NCT01458743](https://clinicaltrials.gov/study/NCT01458743)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Pfizer
- **Collaborators:** Forest Laboratories
- **Conditions:** Healthy
- **Start Date:** 2011-10
- **Completion Date:** 2012-04
- **CT.gov Last Update:** 2017-09-05

## Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.

## Detailed Description

A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
* Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
* Be willing to communicate with the investigator and comply with all study procedures.

Exclusion Criteria:

* Creatine clearance \<80 mL/min as calculated by the Cockcroft Gault equation
* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
* Symptoms of any clinically significant illness within 2 weeks of screening.
* Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
* Blood donation with 3 months of screening.
```

## Arms

- **Ceftaroline q12h** (EXPERIMENTAL) — Ceftaroline 600mg q12h
- **Ceftaroline q8h** (EXPERIMENTAL) — ceftaroline 600mg q8h

## Interventions

- **Ceftaroline** (DRUG) — 60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.
- **Ceftaroline** (DRUG) — Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.

## Primary Outcomes

- **Area under the concentration curve of Ceftaroline over the time (AUC).** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline over the time (AUC).** _(time frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline over the time (AUC).** _(time frame: Group 2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline.** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline.** _(time frame: Group2:Days 2 through 7: Pre-dose Day 8: Pre-dose, 60 min,90 min,115 min,125 min,2 hr15min,2.5hr,3 hr,4 hr,6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug)_
- **Area under the concentration curve of Ceftaroline over the time (AUC)** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline over the time (AUC)** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_

## Secondary Outcomes

- **Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).** _(time frame: Group2:Days 2 through 7:Pre-dose Day8: Pre-dose,60 min,90 min,115 min,125 min, 2 hr 15min,2.5hr,3 hr,4 hr,6hr,8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Number of patients with adverse events.** _(time frame: From baseline to day 10)_
- **Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)** _(time frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr 15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)** _(time frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr, 12hr, 18hr, 24hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline fosamil over the time (AUC).** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline fosamil over the time (AUC).** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline fosamil** _(time frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline fosamil** _(time frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline fosamil over the time (AUC).** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline fosamil over the time (AUC).** _(time frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug.)_
- **Area under the concentration curve of Ceftaroline fosamil over the time (AUC).** _(time frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline fosamil** _(time frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline fosamil** _(time frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr 15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug.)_
- **Maximum plasma concentration (Cmax) of Ceftaroline fosamil** _(time frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.)_

## Locations (1)

- Beijing, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|beijing||china` — added _(2026-05-12)_

---

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