GSK-205731

Study Sponsor: GSK

Study Title

An open-label, randomised, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 mg/5 mL suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions

Medicine or Vaccine (generic name)

cefixime

Sponsor Identification Number

205731

Trial Registry Identification Number(#'s)

NCT03408392

Medical Condition

Infections, Bacterial

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=205731

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT03408392

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

An analysis-ready dataset and a reporting and analysis plan are not available for this study.

Date Added to this Site

November 2019