Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

August 28, 2017

Study Completion Date

August 28, 2017

Conditions
Infections, Bacterial
Interventions
DRUG

GR37547 tablet

"A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed GSK500on lower side."

DRUG

Ciprofloxacin reference tablet

"A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water. Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500 marked on upper side and BAYER on lower side."

Trial Locations (1)

9301

GSK Investigational Site, Bloemfontein

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY