Study to Compare Blood Levels of Ceftriaxone Given by Suppository or Injection.
Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
Phase 1, three-way cross-over, randomised, open label comparison of intravenous versus two
rectal dosage forms of ceftriaxone in 37 healthy Thai adults.
The following regimens will be evaluated in random order in all participants:
A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form
test formulation 1 (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2 (1 x
500mg)
Possible schedules: ABC, ACB, BAC, BCA, CAB, CBA. Each recipient will receive a single
treatment dose of each of the three formulations in an order predetermined by a computer
generated randomisation list. This will be a constrained randomisation which ensures
approximately balanced proportions for all six schedules (either 6 or 7 patients per
schedule). There will be a minimum 7 day washout period between doses. The last follow up
visit is 28 (+ 2) days after final dose. Participants lost to follow-up or unevaluable for
any reason before completion of pharmacokinetic sampling after the final dose will be
replaced at the discretion of the investigators with another participant of the same
population, if either sample size or completeness of dataset is compromised.