Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
Condition: Healthy
Intervention: L-PZQ ODT; Rac-PZQ ODT; L-PZQ ODT; Rac-PZQ ODT; Cesol®
Intervention description: L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water; Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water; L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water; Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water; Cesol® tablet at a dose of 150 mg crushed in water
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; L-PZQ; PZQ; MSC2499550A; Praziquantel

Summary:

      The primary objective of the trial is to compare the "overall palatability" of the new orally
      disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the
      current available racemate PZQ tablets (reference) as assessed by means of human gustatory
      sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the
      incorporation of a 5 point facial hedonic scale).

      The secondary objectives are

        -  To obtain feedback from children regarding the taste of different formulations using an
           open ended questionnaire

        -  To document any discomfort or other observation in relation to acceptance of the study
           medication
    

Eligibility criteria:

        Inclusion criteria:

          1. Children male or female aged 6-11 years (inclusive)

          2. Parents or guardians gave written informed consent prior to any trial related
             procedure and child gave assent

          3. Able to communicate well with the Investigator, understanding the protocol
             requirements and restrictions, and willing to comply with the requirements of the
             entire trial

          4. Subjects should be able to hold 2 milliliter (mL) of any appropriate juice in their
             mouth for 10 seconds without swallowing it and to keep a candy in the mouth for 20
             seconds without swallowing it

          5. Children who are able to properly assess and differentiate flavours of different soft
             drinks

          6. Children who are able to use a hedonic scale (children were trained before the study)

        Exclusion criteria:

          1. Unlikely to comply with the protocol requirements, instructions and trial-related
             restrictions, example: uncooperative attitude, inability to return for follow-up
             visits, and improbability of completing the trial

          2. Children with any condition or dietary habit known to interfere with the sense of
             smell and taste, ingestion of any medication (except paracetamol)

          3. Children with significant illness in the previous 2 weeks

          4. Any surgical or medical condition, or any significant disease that in the opinion of
             the investigator, constitutes a risk or a contraindication for the participation of
             the subject in the study that could interfere with the study objectives, conduct or
             evaluation

          5. Children who have participated in any clinical investigation within the previous 4
             weeks