Impact of Formulation on Ciprofloxacin Oral Absorption

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 any good. Tablets contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the tablet, and the way in which the tablet is manufactured, both can impact how much drug is absorbed into the body. That is, tablet formulation factors can cause a tablet to be effective or not effective.

Tablets in this research contain the drug ciprofloxacin hydrochloride. Ciprofloxacin is an antibiotic to treat infections, such as lung infections. This drug is being used since it has low water solubility and is probably sensitive to tablet formulation factors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Ciprofloxacin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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