Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
NCT ID: NCT02325713
Last Updated: 2017-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A-B-C1-D1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence A-B-C1-D2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence A-B-C2-D1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence A-B-C2-D2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence A-B-D1-C1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence A-B-D2-C1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence A-B-D1-C2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence A-B-D2-C2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence B-A-C1-D1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence B-A-C1-D2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence B-A-C2-D1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence B-A-C2-D2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence B-A-D1-C1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence B-A-D2-C1
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Sequence B-A-D1-C2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Sequence B-A-D2-C2
Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Interventions
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Oral dispersible tablet of praziquantel (ODT-PZQ)
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
Cysticide
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQ
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQ
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
Cysticide
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male subjects with partners of childbearing potential must have had a vasectomy or use acceptable methods of birth control (that is, condoms) and not donate sperm during, and until 90 days after the last dose of the trial medication
* Provide written informed consent prior to any trial related procedure
* Body weight of greater than or equal to (\>=)55.0 kg to less than (\<) 95.0 kg and a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2)
* Able to communicate well with the Investigator, understand the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial
* Non-smoker (= 0 cigarettes, pipes, cigars or other) from at least 3 months prior to start of trial
* Electrocardiogram (ECG) recording (12-lead) without signs of clinically relevant pathology, in particular QTcB \< 450 milliseconds (ms)
* Vital signs (systolic blood pressure, diastolic blood pressure and pulse) in supine position are within the normal range or show no clinically relevant deviation as judged by the Investigator
Exclusion Criteria
* History of gastrointestinal (GI) tract surgery, other GI tract diseases or acute GI tract infections within the last 2 weeks that could influence the GI absorption and/or motility according to the Investigator's opinion
* Any clinically relevant abnormality in the safety laboratory parameters as judged by the Investigator
* Positive results from serology examination for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
* Have an ascertained or presumptive contraindication or hypersensitivity to the active drug substance and/or formulations' ingredients
* Have any clinically significant history of allergic conditions which the Investigator considers may affect the outcome of the trial
* History or presence of drug abuse or alcohol abuse (as defined by the assessment of the investigator) at screening and on each admission
* Blood donation or loss of more than 400 mL of blood within 3 months before the first administration of the investigational product
* Administration of any investigational product or use of any investigational device within 60 days prior to first dosing that may affect the pharmacokinetics of the investigational product
* Subjects who have used drugs that may affect the pharmacokinetics (PK) of PZQ from 15 days before the first administration of the investigational product until the last PK sample
* Consumption of substances known to be potent inhibitors or inducers of cytochrome P450s (CYPs) within 2 weeks before the first administration of the investigational product
* Unlikely to comply with the protocol requirements, instructions and trial-related restrictions
* Non-acceptance of the study breakfast
* Excessive consumption of beverages containing xanthine (greater than \[\>\] 5 cups of coffee a day or equivalent) and the inability to refrain from the use of caffeine-containing beverages from 48 hours before the first administration of the investigational product until discharge from the clinic
* Subject 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 subjects
* Legal incapacity or limited legal capacity
18 Years
55 Years
MALE
Yes
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Please contact the Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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Other Identifiers
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200585-001
Identifier Type: -
Identifier Source: org_study_id
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