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This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A-B-C1-D1 | Experimental |
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| Sequence A-B-C1-D2 | Experimental |
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| Sequence A-B-C2-D1 | Experimental |
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| Sequence A-B-C2-D2 | Experimental |
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| Sequence A-B-D1-C1 | Experimental |
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| Sequence A-B-D2-C1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral dispersible tablet of praziquantel (ODT-PZQ) | Drug | Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ. | Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | |
| Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
Overall, 65 subjects were screened, for inclusion in this trial. Of which, 32 subjects were enrolled and randomized to a treatment sequence.
First/Last subject (informed consent): 21 January 2015/21 January 2015. Study completion date: 09 March 2015. The study was conducted at one center in South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A-B-C1-D1 | Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG001 | Sequence A-B-C1-D2 | Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG002 | Sequence A-B-C2-D1 | Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG003 | Sequence A-B-C2-D2 | Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG004 | Sequence A-B-D1-C1 | Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG005 | Sequence A-B-D2-C1 | Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG006 | Sequence A-B-D1-C2 | Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG007 | Sequence A-B-D2-C2 | Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG008 | Sequence B-A-C1-D1 | Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG009 | Sequence B-A-C1-D2 | Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG010 | Sequence B-A-C2-D1 | Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG011 | Sequence B-A-C2-D2 | Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG012 | Sequence B-A-D1-C1 | Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG013 | Sequence B-A-D2-C1 | Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG014 | Sequence B-A-D1-C2 | Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| FG015 | Sequence B-A-D2-C2 | Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Intervention Period 1 (2 Days) |
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| Intervention Period 2 (2 Days) |
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| Intervention Period 3 (2 Days) |
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| Intervention Period 4 (2 Days) |
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The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A-B-C1-D1 | Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ. | The pharmacokinetic (PK) population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, 'N' (number of participants analyzed) signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter (h*ng/mL) | Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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Baseline up to end of treatment (up to Day 32)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Sequence A-B-D1-C2 | Experimental |
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| Sequence A-B-D2-C2 | Experimental |
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| Sequence B-A-C1-D1 | Experimental |
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| Sequence B-A-C1-D2 | Experimental |
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| Sequence B-A-C2-D1 | Experimental |
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| Sequence B-A-C2-D2 | Experimental |
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| Sequence B-A-D1-C1 | Experimental |
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| Sequence B-A-D2-C1 | Experimental |
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| Sequence B-A-D1-C2 | Experimental |
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| Sequence B-A-D2-C2 | Experimental |
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| Cysticide | Drug | Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal. |
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| ODT-PZQ | Drug | Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal. |
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| ODT-PZQ | Drug | Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal. |
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| ODT-PZQ | Drug | Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal. |
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| Cysticide | Drug | Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal. |
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| Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ | Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ | AUCextra was reported in terms of percentage of AUC0-inf. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ | λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ | Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference). | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
| Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug. | Baseline up to end of treatment (up to Day 32) |
| Palatability Assessment Based on Visual Analog Scale (VAS) Score | Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates "Did not like" and 100 indicates "very much liked". Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication. | Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment |
| Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters | Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis. | Baseline up to end of treatment (up to Day 32) |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Sequence A-B-C1-D2 | Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG002 | Sequence A-B-C2-D1 | Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG003 | Sequence A-B-C2-D2 | Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG004 | Sequence A-B-D1-C1 | Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG005 | Sequence A-B-D2-C1 | Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG006 | Sequence A-B-D1-C2 | Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG007 | Sequence A-B-D2-C2 | Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG008 | Sequence B-A-C1-D1 | Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG009 | Sequence B-A-C1-D2 | Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG010 | Sequence B-A-C2-D1 | Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG011 | Sequence B-A-C2-D2 | Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG012 | Sequence B-A-D1-C1 | Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG013 | Sequence B-A-D2-C1 | Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG014 | Sequence B-A-D1-C2 | Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG015 | Sequence B-A-D2-C2 | Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period. |
| BG016 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. |
| OG001 | Treatment B: 40 mg/kg Cysticide Tablet After Meal | Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods. |
| OG002 | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. |
| OG003 | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. |
| OG004 | Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal | Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods. |
| OG005 | Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal | Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods. |
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| Secondary | Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ | Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, "n" signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ | AUCextra was reported in terms of percentage of AUC0-inf. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, "n" signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of AUC0-inf | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ | λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, "n" signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ | Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference). | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent bioavailability | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, "n" signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, "n" signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ. | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment |
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| Secondary | Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug. | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | Posted | Number | subjects | Baseline up to end of treatment (up to Day 32) |
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| Secondary | Palatability Assessment Based on Visual Analog Scale (VAS) Score | Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates "Did not like" and 100 indicates "very much liked". Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication. | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | Posted | Mean | Standard Deviation | millimiter (mm) | Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment |
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| Secondary | Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters | Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis. | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | Posted | Number | subjects | Baseline up to end of treatment (up to Day 32) |
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|
| 0 |
| 31 |
| 5 |
| 31 |
| EG001 | Treatment B: 40 mg/kg Cysticide Tablet After Meal | Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods. | 0 | 32 | 4 | 32 |
| EG002 | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. | 0 | 15 | 1 | 15 |
| EG003 | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods. | 0 | 15 | 6 | 15 |
| EG004 | Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal | Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods. | 0 | 14 | 0 | 14 |
| EG005 | Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal | Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods. | 0 | 15 | 3 | 15 |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D-PZQ |
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| Racemate PZQ |
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| D-PZQ |
|
| racemate PZQ |
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| D-PZQ (n= 30,30,15,15,14,15) |
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| racemate PZQ (n= 30,30,15,15,14,15) |
|
| D-PZQ |
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| racemate PZQ |
|
| D-PZQ |
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| racemate PZQ |
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| D-PZQ (n= 30,30,15,15,14,15) |
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| racemate PZQ (n= 30,30,15,15,14,15) |
|
| D-PZQ (n= 30,30,15,15,14,15) |
|
| racemate PZQ (n= 30,30,15,15,14,15) |
|
| Title | Measurements |
|---|---|
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| D-PZQ (n= 30,30,15,15,14,15) |
|
| racemate PZQ (n= 30,30,15,15,14,15) |
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| D-PZQ (n= 30,30,15,15,14,15) |
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| racemate PZQ (n= 30,30,15,15,14,15) |
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| racemate PZQ |
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| Serious TEAEs |
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| TEAE leading to Discontinuation |
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| Day 1, 0 Hour: Smell |
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| Day 1, 0 Hour: Sweetness |
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| Day 1, 0 Hour: Overall liking |
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| Day 1, 2-5 Min After Medicine: Taste in Mouth |
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| Day1,2-5 Min After Medicine:Acceptable to Swallow |
|