Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
Condition: Healthy
Intervention: Cesol (Test); Biltricide (Reference)
Intervention description: Participant will receive coated cesol tablet in sequence 1 (Day 1 and Day 15) and in sequence 2 (Day 8 and Day 22). A washout period of 7 days will be maintained between 4 treatment periods.; Participant will receive biltricide tablet in Sequence 1 (Day 8 and Day 22) and in sequence 2 (Day 1 and Day 15). A washout period of 7 days will be maintained between 4 treatment periods.
Intervention MeSH terms: Praziquantel
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; Bioequivalence; Praziquantel; Cesol; Pharmacokinetics

Summary:

      The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet
      (Test) versus Biltricide tablets (Comparator) in healthy male participants. Praziquantel
      (rac-PZQ) is the active ingredient for Cesol and Biltricide tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are overtly healthy as determined by medical evaluation, including
             medical history, physical examination, laboratory tests, and cardiac monitoring

          -  Nonsmoker (=0 cigarettes, pipes, cigars or others) since at least 3 months

          -  Have a body weight within 55.0 to 95.0 kilogram (kg) and body mass index within the
             range of 18.5 to 29.9 kilogram per meter squared (kg/m^2)

          -  Electrocardiogram recording (12-lead) without signs of clinically relevant pathology
             in particular heart-rate corrected [QTc] (Bazett) <450 milliseconds (ms)

          -  Vital signs should be in normal range (systolic blood pressure: 90 to 140 millimeters
             of mercury [mmHg]; diastolic blood pressure: 50 to 90 mmHg; pulse rate: 50 to 90 beats
             per minute [bpm]; auricular body temperature between 35.9 degree centigrade [°C] to
             37.6°C)

          -  Are males agreeing to refrain from donating sperm, Use a male condom when having
             sexual intercourse with a woman of child-bearing potential, who is not currently
             pregnant, and advise her to use a highly effective contraceptive method with a failure
             rate of less than (< )1 percent (%) per year

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Any condition, including any clinically relevant abnormality in the safety laboratory
             parameters as judged by the Investigator, that in the Investigator's opinion
             constitutes an inappropriate risk or a contraindication for participation in the study
             or that could interfere with the study objectives, conduct, or evaluation

          -  Have positive results from serology examination for Hepatitis B surface antigen
             (indicative of active Hepatitis B), Hepatitis C Virus or Human Immunodeficiency Virus
             (Human Immunodeficiency Virus 1/2 antibodies)

          -  Participants who have used drugs that may affect the pharmacokinetics of rac-PZQ from
             15 days before dosing until the last PK sample, example., phenytoin, barbiturates,
             primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin,
             nelfinavir, ritonavir, griseofulvin, oral ketoconazole

          -  Positive test for drugs of abuse (including alcohol) at Screening and prior to each
             dosing

          -  Unlikely to comply with the protocol requirements, instructions and study-related
             restrictions; example, uncooperative attitude, inability to return for follow-up
             visits, and improbability of completing the study

          -  Participant is the Principal Investigator or any Sub investigator, research assistant,
             pharmacist, study coordinator, other staff or relative thereof directly involved in
             the conduct of the study

          -  Inability to communicate or cooperate with the Investigator (example. language
             problem, illiterates, poor mental status) or to comply with the requirements of the
             entire study, including dietary restrictions

          -  Vulnerable participants (example., persons kept in detention).

          -  Legal incapacity or limited legal capacity

          -  Other protocol defined exclusion criteria could apply