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Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Last updated on May 11, 2018

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Study Location
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00376324
Pfizer
Completed
Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

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Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Subjects
Drug: Tigecycline
Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00376324
3074A1-119
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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