A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 11, 2018

Primary Completion Date

February 2, 2018

Study Completion Date

February 2, 2018

Conditions
Infections, Bacterial
Interventions
DRUG

Cefixime test capsule

"SKF101804/cefixime test capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as a dark purple head and off white body locking type capsule with GSK' printed on cap and 400MG printed on body of capsule."

DRUG

Cefixime reference capsule

"Cefixime reference capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as red/orange hard gelatin size 0 capsule with Cefspan 400 mg printed on body of capsule."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY