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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Collaborator: |
Halozyme Therapeutics |
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00493220 |
Purpose
The objectives of this study are:
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: hyaluronidase (human recombinant) and ceftriaxone Drug: placebo and ceftriaxone Drug: ceftriaxone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone (INFUSE-Ceftriaxone) Study: A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYLENEX Recombinant) and Intravenously in Human Volunteers |
| Enrollment: | 54 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: hyaluronidase (human recombinant) and ceftriaxone
Single subcutaneous dose: 150 U hyaluronidase (human recombinant) immediately prior to 1 gm ceftriaxone
|
| 2: Placebo Comparator |
Drug: placebo and ceftriaxone
Single subcutaneous dose: saline immediately prior to 1 gm ceftriaxone
|
| 3: Active Comparator |
Drug: ceftriaxone
single intravenous dose: 1 gm ceftriaxone
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Baxter Healthcare Corporation ( Geroge E. Harb, MD ) |
| Study ID Numbers: | 1838-004 |
| Study First Received: | June 26, 2007 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00493220 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ceftriaxone cephalosporins pharmacokinetics subcutaneous |
hyaluronoglucosaminidase hyaluronidase hyaluronan rHuPH20 |
|
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Ceftriaxone Pharmacologic Actions |