Healthy Subjects Clinical Trial
Official title:
An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone
Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion: - Men and nonlactating and nonpregnant women greater than or equal to 18 years of age. - Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG). - Have a high probability for compliance with and completion of the study. Exclusion: - Subjects with chronic osteomyelitis. - Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines. - Involvement in other investigational studies of any type within 30 days before test article administration. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. | 1 day | No |
Status | Clinical Trial | Phase | |
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