Praziquantel Bioequivalence Study
Condition: Healthy
Intervention: Cisticid; Biltricide
Intervention description: Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).; Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Intervention MeSH terms: Praziquantel
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; Bioequivalence; Praziquantel; Cysticide; Pharmacokinetics

Summary:

      The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg)
      Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in
      healthy male participants. Praziquantel (PZQ) is the active ingredient for Cisticid and
      Biltricide tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male participant must agree to use and to have their female partners willing to use
             additional non-hormonal contraception (for example, condoms or occlusive cap with
             spermicide, non-hormonal intra-uterine device [IUD], previous sterilization of
             participant or his partner, being sexually inactive) from Day of randomization up to
             final end of treatment (EOT) visit

          -  Gave written informed consent prior to any trial related procedure

          -  Have a body weight (BW) of greater than (>) 55.0 kilogram (kg) to less than (<) 95 kg
             and a body mass index (BMI) between 18.0 and 27.0 kg/meter square (m^2)

          -  Able to communicate well with the Investigator, understanding the protocol
             requirements and restrictions, and willing to comply with the requirements of the
             entire trial

          -  Non-smoker (= 0 cigarettes, pipes, cigars or others) since at least three months

          -  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: 45 to 90 beats
             per minute [bpm]; oral body temperature between 35.0 degree centigrade [°C] to 37.5°C)

          -  All values for biochemistry, liver function test and hematology tests of blood and
             urine within the normal range or showing no clinically relevant deviation as judged by
             the Investigator. Hematocrit and hemoglobin must be above the lower limit; upper limit
             may range up to 15 percent (%). Remaining results, including white blood cells may
             range +/- 15%, if participant is asymptomatic

          -  Negative screen for alcohol and drugs of abuse (opiate class, barbiturates, cocaine
             and metabolites, amphetamines, cannabinoids, benzodiazepines and tricyclic
             antidepressants) at screening and on each admission

          -  Negative screen for Hepatitis B surface (HBs) antigens, Hepatitis C Virus (HCV)
             antibodies, Hepatitis A Virus (HAV) antibodies and Human Immunodeficiency Virus (HIV)
             1 and 2 antibodies

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Any surgical or medical condition, including findings in the medical history or in the
             pre-study assessments, or any other significant disease, that in the opinion of the
             Investigator, constitutes a risk or a contraindication for the participation of the
             participant in the study or that could interfere with the study objectives, conduct or
             evaluation

          -  History of surgery of the gastrointestinal (GI) tract, history of other GI tract
             diseases, or acute GI tract infections in the last 2 weeks, which could influence the
             gastrointestinal absorption and/or motility according to the Investigator's opinion

          -  Any clinically relevant abnormality in the safety laboratory parameters as judged by
             the Investigator

          -  Have positive results from serology examination for Hepatitis B surface (HBs) antigen,
             Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)

          -  Allergy: ascertained or presumptive hypersensitivity to the active drug substance
             and/or formulations' ingredients; history of anaphylaxis to drugs or allergic
             reactions in general, which the Investigator considers may affect the outcome of the
             trial

          -  History or presence of drug abuse (opiate class, barbiturates, cocaine and its main
             metabolite, amphetamines, cannabinoids, benzodiazepines and tricyclic antidepressants)
             or alcohol abuse at screening and on each admission. Alcohol abuse is defined by the
             assessment of the Investigator

          -  Loss or donation of more than 400 milliliter (mL) of blood within 90 days prior to
             first Praziquantel (PZQ) administration

          -  Administration of any investigational product or use of any investigational device in
             any clinical study within 30 days prior to first PZQ administration. Participants who
             have used drugs that may affect the pharmacokinetics of PZQ from 14 days before dosing
             until the last pharmacokinetic (PK) sample, for example, phenytoin, barbiturates,
             primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin,
             nelfinavir, ritonavir, griseofulvin, oral ketoconazole

          -  Consumption of substances known to be potent inhibitors or inducers of Cytochrome
             P450s (CYP P450s) such as grapefruit, orange, cranberry or juices of these fruits,
             herbal remedies or dietary supplements containing St. John's Wort, poppy seeds,
             cruciferic vegetables, in the two weeks before dosing until last PK sample

          -  Unlikely to comply with the protocol requirements, instructions and trial-related
             restrictions, for example, uncooperative attitude, inability to return for follow-up
             visits, and improbability of completing the trial

          -  Non-acceptance or non-compliance with the study breakfast (for example, vegetarians,
             vegans and participants who follow special diets)

          -  Excessive consumption of beverages containing xanthine (>5 cups of coffee a day or
             equivalent) or inability to stop consuming caffeine from 48 hours prior to drug
             administration until discharge from the clinic

          -  Participant is the Investigator or any Sub-Investigator, research assistant,
             pharmacist, trial coordinator, other staff or relative thereof directly involved in
             the conduct of the trial

          -  Vulnerable participants (for example, persons kept in detention)

          -  Legal incapacity or limited legal capacity

          -  Other protocol defined exclusion criteria could apply