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Zoliflodacin Bioequivalence and Drug-Drug Interaction Study

NCT05635305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-01

No results posted yet for this study

Summary

this study will be a Phase 1, single-dose, two parallel cohorts, open-label, randomized study in healthy subjects with Cohort 1 as bioequivalence (BE) and food effect study and Cohort 2 as a drug-drug interaction (DDI) study.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Zoliflodacin Patheon

Zoliflodacin Patheon formulation to be compared with Zoliflodacin Dr Reddy's formulation during BE study (cohort 1). Itraconazole will be administered with Zoliflodacin Patheon formulation during DDI study (cohort 2)

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • KCAS

    collaborator UNKNOWN

  • Global Antibiotics Research and Development Partnership

    lead OTHER

Principal Investigators

  • Salman Nasr, MD · Parexel CPU Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2023-02-07
Completion
2023-02-07
FDA Drug
Yes

Countries

  • Germany

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 NCT05635305 on ClinicalTrials.gov