Status:
COMPLETED
Impact of Formulation on Ciprofloxacin Oral Absorption
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this research is to see if certain tablet formulation factors affect oral drug absorption. Medications taken by mouth, such as tablets, need to be absorbed into the body in order to do ...
Detailed Description
Dogs and humans exhibit differences in gastrointestinal physiology. The development of pharmaceuticals for both humans and dogs typically depends upon pharmacokinetic studies in the other species. Pro...
Eligibility Criteria
Inclusion
- Male or female
- Age 18-55
- Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit
- Willing to avoid caffeine containing products 24 hours prior to and day of study visits
- Willing to stop all OTC medications for 24 hours prior to and during study visits
- Able to provide informed consent
Exclusion
- Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
- Presence of hepatic, renal disease
- Pregnant women, breast feeding or trying to become pregnant
- Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol)
- Routine use (i.e. daily or weekly) prescription medication except birth control pills
- Routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function
- Currently taking ciprofloxacin or tizanidine
- Allergic to ciprofloxacin or any quinolone-type antibiotic (e.g. levofloxacin)
- Currently taking a corticosteroid drug (e.g. prednisone)
- Had a kidney, heart, or lung transplant
- Any condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00992329
Start Date
January 1 2013
End Date
November 1 2013
Last Update
November 6 2020
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201