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Study to Compare Blood Levels of Ceftriaxone Given by Suppository or Injection.

NCT03895567 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-26

No results posted yet for this study

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-hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2-rectodispersible mannitol-based tablet (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 randomization which ensures approximately balanced proportions for all six schedules (either 6 or 7 participants per schedule). There will be 7-28 days 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.

This study is funded by the Medical Research Council. The grant reference number is MR/W021560/1

Conditions

  • Healthy

Interventions

DRUG

A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection)

Parenteral ceftriaxone Intravenous injection of 500mg of ceftriaxone sodium (Rocephin®; Roche).

DRUG

B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg)

Rectal ceftriaxone formulations Formulation 1 ceftriaxone 500mg + Na-CDC 125mg hard-shell gelatin capsule

DRUG

C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)

Rectal ceftriaxone formulations Formulation 2 ceftriaxone 500mg + Na-CDC 125mg rectodispersible mannitol-based tablet

Sponsors & Collaborators

  • Biopharma (Orofino Pharmaceuticals Group)

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Elizabeth Ashley, MD · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895567 on ClinicalTrials.gov