Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Ertapenem 1 gram intravenous (IV) 5 minute bolus

Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.

Group Type EXPERIMENTAL

ertapenem

Intervention Type DRUG

1 gram IV bolus every 24 hours (q24h) for 3 days

Ertapenem 1 gram IV 30 minute infusion

Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).

Group Type ACTIVE_COMPARATOR

ertapenem

Intervention Type DRUG

1 gram 30 minute infusion q24h for 3 days

Interventions

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ertapenem

1 gram IV bolus every 24 hours (q24h) for 3 days

Intervention Type DRUG

ertapenem

1 gram 30 minute infusion q24h for 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults (18 years of age or older)

Exclusion Criteria

* Ertapenem or other beta-lactam allergy
* Pregnant or breast feeding females
* Body Mass Index (BMI) greater than or equal to 30
* Abnormal lab values at baseline
* Hypertension
* Significant medical abnormality
* Regular alcohol consumption
* Significant nicotine use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes