NCT00992329

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
3.2 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

October 2, 2009

Last Update Submit

November 5, 2020

Conditions

Healthy

Keywords

ciprofloxacinpharmacokineticsformulation

Outcome Measures

Primary Outcomes (1)

  • Amount of ciprofloxacin absorbed

    Blood samples will be collected to measure level of ciprofloxacin.

    10 hours

Secondary Outcomes (1)

  • Difference between humans and dogs in the amount of cipro absorbed.

    10 hours

Study Arms (4)

ciprofloxacin tab1

EXPERIMENTAL

formulation 1

Drug: ciprofloxacin

ciprofloxacin tab2

EXPERIMENTAL

formulation 2

Drug: ciprofloxacin

ciprofloxacin tab 3

EXPERIMENTAL

formulation 3

Drug: ciprofloxacin

ciprofloxacin reference

ACTIVE COMPARATOR

reference product

Drug: ciprofloxacin

Interventions

ciprofloxacinDRUG

ciprofloxacin 200mg tablet (single dose)

ciprofloxacin referenceciprofloxacin tab 3ciprofloxacin tab1ciprofloxacin tab2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Polli JE, Rekhi GS, Augsburger LL, Shah VP. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J Pharm Sci. 1997 Jun;86(6):690-700. doi: 10.1021/js960473x.

    PMID: 9188051BACKGROUND

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • James Polli

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 9, 2009

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

US(1)