Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Cohort 1 (BE) is a four-period, four-sequence, four-treatment crossover BE and food effect
      study of zoliflodacin granules for oral suspension manufactured by Dr. Reddy's (test product,
      ZoliDr) and those manufactured by Patheon (reference product, ZoliPa) as a 3 g oral dose
      under fasting and a [specific] fed condition. This cohort will comprise of approximately 32
      subjects (8 healthy subjects per treatment sequence) in 4 x 4 BE treatment arms in fasted and
      [specific] fed conditions. Healthy subjects will be randomized into 4 parallel treatment
      sequences to receive sequential Treatments A, B, C, and D in William's Square design pattern
      where:

        -  Treatment A is ZoliPa fasted

        -  Treatment B is ZoliDr fasted

        -  Treatment C is ZoliPa [specific] fed condition

        -  Treatment D is ZoliDr [specific] fed condition

      Based on William's Square design, below treatment sequences will be followed:

      A-B-C-D B-A-D-C C-D-A-B D-C-B-A

      There will be 4 treatment periods, each with a single dose of the investigational medicinal
      products (IMP).

      The washout period between each IMP administration will be at least 72 hours. Food regimen:
      Subjects, who are in a treatment period in which they are [specific] fed, will be dosed 30
      minutes after the start of food intake. The subjects are expected to consume the entire meal
      within 30 minutes prior to dosing.

      Cohort 2 (DDI): This is an open-label, 2-period, 2-treatment, fixed sequence crossover DDI
      study in healthy subjects. It will investigate PK of zoliflodacin (ZoliPa) in the absence and
      presence of itraconazole. Approximately 18 subjects will receive ZoliPa on Day 1 under
      fasting condition. After a washout of 72 hours after dosing of ZoliPa, on Day 4, subjects
      will receive a 400 mg loading dose of itraconazole followed by 200 mg of itraconazole once
      daily from Day 5-8. From Day 4 to Day 8, itraconazole will be administered immediately after
      a full meal. On Day 9, both itraconazole and zoliflodacin (ZoliPa) will be administered under
      fasting conditions at -1 hours and 0 hours, respectively. Itraconazole will then be
      administered with food at 24 hours (Day 10) and 48 hours (Day 11) after administration of
      zoliflodacin (ZoliPa).
    

Intervention name(s): Zoliflodacin Patheon
Intervention type(s): Drug
Intervention description(s): 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)
Intervention MeSH terms: Zoliflodacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: BE study (cohort 1) will be managed in parallel with the DDI study (cohort 2)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Drug Drug Interaction