Obesity Clinical Trial
Official title:
Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients
Verified date | August 2012 |
Source | Basilea Pharmaceutica |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Body mass index (BMI) =or > 40 kg/m2 or normal BMI between 18-30 - Blood pressure 90-140 mm - Non-smoker Exclusion Criteria: - History of medically significant illness - Uncontrolled hypertension - Uncontrolled high blood cholesterol and triglycerides |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basilea Pharmaceutica | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients | up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up). | No | |
Secondary | To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients. | Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up) | No | |
Secondary | To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population. | Throughout the study from Day -1 through the post-study follow up | No |
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