A randomised crossover study of the pharmacokinetics, safety and tolerability of two rectal formulations of ceftriaxone compared to parenteral ceftriaxone, in healthy Thai adults

niversity of Oxford0 sites37 target enrollmentDecember 6, 2022

Overview

No summary available.

Registry

who.int

Start Date

December 6, 2022

End Date

August 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Healthy male or non\-pregnant female, aged 18 to 46 years (inclusive)
•2\. Willing and able to give informed consent to participate in the trial
•3\. Able, in the investigator's opinion, and willing to comply with the study requirements and follow\-up

•Current participant exclusion criteria as of 07/03/2023:
•1\. Female participant who is pregnant, lactating or planning pregnancy during the course of the study
•2\. Presence of any condition which in the judgment of the investigator would affect the absorption of the rectal formulation e.g. previous surgery, haemorrhoids, inflammatory bowel disease
•3\. Irritable bowel syndrome (IBS) or diarrhoea in the 24 hours prior to the study drug administration
•4\. Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)
•5\. Seropositive for HIV at screening
•6\. Hepatitis B surface antigen (HBsAg) detected in serum at screening
•7\. Seropositive for hepatitis C virus (antibodies to HCV) at screening
•8\. Participation in a clinical trial and/or has received a drug or a new chemical entity within 30 days or 5 half\-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication and throughout the study period
•9\. Any medical condition that in the judgment of the investigator would make the administration of the study treatments unsafe