Trial Outcomes & Findings for Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers (NCT NCT02325713)
NCT ID: NCT02325713
Last Updated: 2017-02-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
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
Results posted on
2017-02-23
Participant Flow
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.
Overall, 65 subjects were screened, for inclusion in this trial. Of which, 32 subjects were enrolled and randomized to a treatment sequence.
Participant milestones
| Measure |
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.
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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.
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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.
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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.
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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.
|
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Intervention Period 1 (2 Days)
NOT COMPLETED
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Intervention Period 2 (2 Days)
STARTED
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Intervention Period 2 (2 Days)
COMPLETED
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Intervention Period 2 (2 Days)
NOT COMPLETED
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Intervention Period 3 (2 Days)
STARTED
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Intervention Period 3 (2 Days)
COMPLETED
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Intervention Period 1 (2 Days)
COMPLETED
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Intervention Period 1 (2 Days)
STARTED
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Intervention Period 3 (2 Days)
NOT COMPLETED
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Intervention Period 4 (2 Days)
STARTED
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Intervention Period 4 (2 Days)
COMPLETED
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Intervention Period 4 (2 Days)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Intervention Period 1 (2 Days)
Protocol Non-Compliance
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Intervention Period 2 (2 Days)
Protocol Non-Compliance
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1
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Intervention Period 3 (2 Days)
Withdrawal by Subject
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0
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0
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Baseline Characteristics
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Sequence A-B-C1-D1
n=2 Participants
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.
|
Sequence A-B-C1-D2
n=2 Participants
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.
|
Sequence A-B-C2-D1
n=2 Participants
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.
|
Sequence A-B-C2-D2
n=2 Participants
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.
|
Sequence A-B-D1-C1
n=2 Participants
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.
|
Sequence A-B-D2-C1
n=2 Participants
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.
|
Sequence A-B-D1-C2
n=2 Participants
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.
|
Sequence A-B-D2-C2
n=2 Participants
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.
|
Sequence B-A-C1-D1
n=2 Participants
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.
|
Sequence B-A-C1-D2
n=2 Participants
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.
|
Sequence B-A-C2-D1
n=2 Participants
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.
|
Sequence B-A-C2-D2
n=2 Participants
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.
|
Sequence B-A-D1-C1
n=2 Participants
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.
|
Sequence B-A-D2-C1
n=2 Participants
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.
|
Sequence B-A-D1-C2
n=2 Participants
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.
|
Sequence B-A-D2-C2
n=2 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
32 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
32 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=14 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=14 Participants
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.
|
|---|---|---|---|---|---|---|
|
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)
|
1969.6 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.2
|
2047.9 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 60.2
|
345.4 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 69.5
|
4871.3 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 42.2
|
924.9 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 67.7
|
1537.7 Hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 70.6
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
L-PZQ
|
881.3 ng/mL
Geometric Coefficient of Variation 57.2
|
762.6 ng/mL
Geometric Coefficient of Variation 59.5
|
154.6 ng/mL
Geometric Coefficient of Variation 80.4
|
1548 ng/mL
Geometric Coefficient of Variation 32.6
|
189.3 ng/mL
Geometric Coefficient of Variation 104.0
|
446.3 ng/mL
Geometric Coefficient of Variation 87.6
|
|
Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
D-PZQ
|
2330 ng/mL
Geometric Coefficient of Variation 30.7
|
2179 ng/mL
Geometric Coefficient of Variation 33.0
|
786.3 ng/mL
Geometric Coefficient of Variation 41.5
|
3234 ng/mL
Geometric Coefficient of Variation 20.0
|
838.5 ng/mL
Geometric Coefficient of Variation 65.7
|
1556 ng/mL
Geometric Coefficient of Variation 35.8
|
|
Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
Racemate PZQ
|
3250 ng/mL
Geometric Coefficient of Variation 34.6
|
2974 ng/mL
Geometric Coefficient of Variation 37.2
|
949.9 ng/mL
Geometric Coefficient of Variation 45.1
|
4780 ng/mL
Geometric Coefficient of Variation 23.3
|
1042 ng/mL
Geometric Coefficient of Variation 70.7
|
2040 ng/mL
Geometric Coefficient of Variation 40.9
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ
|
3.000 hours
Interval 1.0 to 4.5
|
1.500 hours
Interval 1.0 to 4.5
|
4.000 hours
Interval 1.5 to 5.0
|
3.000 hours
Interval 0.5 to 4.5
|
4.250 hours
Interval 0.5 to 4.5
|
2.500 hours
Interval 0.5 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ
|
3.000 hours
Interval 1.5 to 4.5
|
2.000 hours
Interval 1.0 to 4.5
|
3.500 hours
Interval 1.5 to 4.5
|
4.000 hours
Interval 0.5 to 4.5
|
4.500 hours
Interval 0.5 to 4.5
|
3.500 hours
Interval 0.5 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ
|
3.000 hours
Interval 1.5 to 4.5
|
1.750 hours
Interval 1.0 to 4.5
|
3.500 hours
Interval 1.5 to 4.5
|
3.500 hours
Interval 0.5 to 4.5
|
4.500 hours
Interval 0.5 to 4.5
|
2.500 hours
Interval 0.5 to 8.0
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ (n= 30,30,14,15,14,14)
|
3.305 hours
Geometric Coefficient of Variation 49.1
|
3.830 hours
Geometric Coefficient of Variation 46.8
|
1.916 hours
Geometric Coefficient of Variation 72.2
|
4.202 hours
Geometric Coefficient of Variation 37.8
|
4.168 hours
Geometric Coefficient of Variation 34.9
|
3.072 hours
Geometric Coefficient of Variation 43.5
|
|
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ (n= 30,30,15,15,14,15)
|
4.577 hours
Geometric Coefficient of Variation 34.7
|
4.618 hours
Geometric Coefficient of Variation 33.8
|
3.962 hours
Geometric Coefficient of Variation 37.2
|
4.346 hours
Geometric Coefficient of Variation 19.4
|
5.281 hours
Geometric Coefficient of Variation 30.1
|
4.347 hours
Geometric Coefficient of Variation 31.2
|
|
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ (n= 30,30,15,15,14,15)
|
4.462 hours
Geometric Coefficient of Variation 34.3
|
4.408 hours
Geometric Coefficient of Variation 35.8
|
3.775 hours
Geometric Coefficient of Variation 38.8
|
4.316 hours
Geometric Coefficient of Variation 24.4
|
4.889 hours
Geometric Coefficient of Variation 29.1
|
4.204 hours
Geometric Coefficient of Variation 30.2
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ
|
0.000 hours
Interval 0.0 to 0.5
|
0.000 hours
Interval 0.0 to 0.5
|
0.000 hours
Interval 0.0 to 0.5
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
|
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.5
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
|
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.5
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
0.000 hours
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
L-PZQ
|
1928.0 h*ng/mL
Geometric Coefficient of Variation 47.4
|
1994.0 h*ng/mL
Geometric Coefficient of Variation 61.1
|
300.5 h*ng/mL
Geometric Coefficient of Variation 75.5
|
4770.1 h*ng/mL
Geometric Coefficient of Variation 41.9
|
863.7 h*ng/mL
Geometric Coefficient of Variation 70.2
|
1342.6 h*ng/mL
Geometric Coefficient of Variation 86.0
|
|
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
D-PZQ
|
7405.9 h*ng/mL
Geometric Coefficient of Variation 28.2
|
8131.4 h*ng/mL
Geometric Coefficient of Variation 39.0
|
2169.2 h*ng/mL
Geometric Coefficient of Variation 46.7
|
14367.2 h*ng/mL
Geometric Coefficient of Variation 34.0
|
4740.6 h*ng/mL
Geometric Coefficient of Variation 56.5
|
6365.5 h*ng/mL
Geometric Coefficient of Variation 41.5
|
|
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
racemate PZQ
|
9476.3 h*ng/mL
Geometric Coefficient of Variation 26.9
|
10266.0 h*ng/mL
Geometric Coefficient of Variation 40.2
|
2515.2 h*ng/mL
Geometric Coefficient of Variation 47.0
|
19262.2 h*ng/mL
Geometric Coefficient of Variation 34.1
|
5694.0 h*ng/mL
Geometric Coefficient of Variation 55.6
|
7929.9 h*ng/mL
Geometric Coefficient of Variation 41.9
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ (n= 30,30,14,15,14,14)
|
1.86 percentage of AUC0-inf
Geometric Coefficient of Variation 51.4
|
2.23 percentage of AUC0-inf
Geometric Coefficient of Variation 66.3
|
5.25 percentage of AUC0-inf
Geometric Coefficient of Variation 97.6
|
1.60 percentage of AUC0-inf
Geometric Coefficient of Variation 79.9
|
5.52 percentage of AUC0-inf
Geometric Coefficient of Variation 72.9
|
2.30 percentage of AUC0-inf
Geometric Coefficient of Variation 63.7
|
|
Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ (n= 30,30,15,15,14,15)
|
1.30 percentage of AUC0-inf
Geometric Coefficient of Variation 97.4
|
1.48 percentage of AUC0-inf
Geometric Coefficient of Variation 90.4
|
2.26 percentage of AUC0-inf
Geometric Coefficient of Variation 56.0
|
1.51 percentage of AUC0-inf
Geometric Coefficient of Variation 106.9
|
3.69 percentage of AUC0-inf
Geometric Coefficient of Variation 110.6
|
1.60 percentage of AUC0-inf
Geometric Coefficient of Variation 97.6
|
|
Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ (n= 30,30,15,15,14,15)
|
1.10 percentage of AUC0-inf
Geometric Coefficient of Variation 101.0
|
1.24 percentage of AUC0-inf
Geometric Coefficient of Variation 104.5
|
1.85 percentage of AUC0-inf
Geometric Coefficient of Variation 59.0
|
1.38 percentage of AUC0-inf
Geometric Coefficient of Variation 133.4
|
3.05 percentage of AUC0-inf
Geometric Coefficient of Variation 117.2
|
1.38 percentage of AUC0-inf
Geometric Coefficient of Variation 104.1
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ (n= 30,30,14,15,14,14)
|
0.210 1/h
Geometric Coefficient of Variation 49.1
|
0.181 1/h
Geometric Coefficient of Variation 46.8
|
0.362 1/h
Geometric Coefficient of Variation 72.2
|
0.165 1/h
Geometric Coefficient of Variation 37.8
|
0.166 1/h
Geometric Coefficient of Variation 34.9
|
0.226 1/h
Geometric Coefficient of Variation 43.5
|
|
Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ (n= 30,30,15,15,14,15)
|
0.151 1/h
Geometric Coefficient of Variation 34.7
|
0.150 1/h
Geometric Coefficient of Variation 33.8
|
0.175 1/h
Geometric Coefficient of Variation 37.2
|
0.159 1/h
Geometric Coefficient of Variation 19.4
|
0.131 1/h
Geometric Coefficient of Variation 30.1
|
0.159 1/h
Geometric Coefficient of Variation 31.2
|
|
Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ (n= 30,30,15,15,14,15)
|
0.155 1/h
Geometric Coefficient of Variation 34.3
|
0.157 1/h
Geometric Coefficient of Variation 35.8
|
0.184 1/h
Geometric Coefficient of Variation 38.8
|
0.161 1/h
Geometric Coefficient of Variation 24.4
|
0.142 1/h
Geometric Coefficient of Variation 29.1
|
0.165 1/h
Geometric Coefficient of Variation 30.2
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ
|
96.175 percent bioavailability
Geometric Coefficient of Variation 46.70
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ
|
90.951 percent bioavailability
Geometric Coefficient of Variation 27.52
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ
|
92.2 percent bioavailability
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ (n= 30,30,14,15,14,14)
|
716.8 Liter/hour
Geometric Coefficient of Variation 45.0
|
691.3 Liter/hour
Geometric Coefficient of Variation 57.9
|
2028.4 Liter/hour
Geometric Coefficient of Variation 60.0
|
438.5 Liter/hour
Geometric Coefficient of Variation 45.8
|
1466.9 Liter/hour
Geometric Coefficient of Variation 60.6
|
971.1 Liter/hour
Geometric Coefficient of Variation 69.5
|
|
Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ (n= 30,30,15,15,14,15)
|
187.2 Liter/hour
Geometric Coefficient of Variation 33.3
|
170.7 Liter/hour
Geometric Coefficient of Variation 42.6
|
316.7 Liter/hour
Geometric Coefficient of Variation 47.6
|
145.5 Liter/hour
Geometric Coefficient of Variation 41.6
|
271.6 Liter/hour
Geometric Coefficient of Variation 62.8
|
227.6 Liter/hour
Geometric Coefficient of Variation 43.7
|
|
Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ (n= 30,30,15,15,14,15)
|
293.3 Liter/hour
Geometric Coefficient of Variation 30.7
|
271.0 Liter/hour
Geometric Coefficient of Variation 42.6
|
548.7 Liter/hour
Geometric Coefficient of Variation 46.4
|
217.1 Liter/hour
Geometric Coefficient of Variation 41.0
|
455.6 Liter/hour
Geometric Coefficient of Variation 60.1
|
366.1 Liter/hour
Geometric Coefficient of Variation 43.2
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ
L-PZQ (n= 30,30,14,15,14,14)
|
3417.6 Liters
Geometric Coefficient of Variation 37.0
|
3820.4 Liters
Geometric Coefficient of Variation 57.5
|
5605.6 Liters
Geometric Coefficient of Variation 63.9
|
2658.4 Liters
Geometric Coefficient of Variation 59.9
|
8820.4 Liters
Geometric Coefficient of Variation 55.3
|
4304.4 Liters
Geometric Coefficient of Variation 50.6
|
|
Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ
D-PZQ (n= 30,30,15,15,14,15)
|
1236.0 Liters
Geometric Coefficient of Variation 43.7
|
1137.4 Liters
Geometric Coefficient of Variation 52.9
|
1810.1 Liters
Geometric Coefficient of Variation 64.8
|
912.1 Liters
Geometric Coefficient of Variation 40.0
|
2069.2 Liters
Geometric Coefficient of Variation 70.5
|
1427.2 Liters
Geometric Coefficient of Variation 41.5
|
|
Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ
racemate PZQ (n= 30,30,15,15,14,15)
|
1887.7 Liters
Geometric Coefficient of Variation 37.3
|
1723.7 Liters
Geometric Coefficient of Variation 53.3
|
2987.7 Liters
Geometric Coefficient of Variation 60.4
|
1352.0 Liters
Geometric Coefficient of Variation 42.7
|
3213.2 Liters
Geometric Coefficient of Variation 61.7
|
2220.2 Liters
Geometric Coefficient of Variation 38.4
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=30 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=30 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
D-PZQ
|
7542.3 h*ng/mL
Geometric Coefficient of Variation 29.2
|
8292.7 h*ng/mL
Geometric Coefficient of Variation 39.4
|
2226.0 h*ng/mL
Geometric Coefficient of Variation 46.1
|
14685.8 h*ng/mL
Geometric Coefficient of Variation 35.5
|
4996.0 h*ng/mL
Geometric Coefficient of Variation 58.5
|
6508.9 h*ng/mL
Geometric Coefficient of Variation 41.8
|
|
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
racemate PZQ
|
9627.2 h*ng/mL
Geometric Coefficient of Variation 28.0
|
10446.9 h*ng/mL
Geometric Coefficient of Variation 40.7
|
2569.5 h*ng/mL
Geometric Coefficient of Variation 46.5
|
19679.5 h*ng/mL
Geometric Coefficient of Variation 35.4
|
5956.0 h*ng/mL
Geometric Coefficient of Variation 57.7
|
8091.8 h*ng/mL
Geometric Coefficient of Variation 42.3
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (up to Day 32)Population: The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=31 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=32 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation
TEAEs
|
5 subjects
|
4 subjects
|
1 subjects
|
6 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation
Serious TEAEs
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation
TEAE leading to Discontinuation
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatmentPopulation: The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=31 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=32 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day 1, 0 Hour: Flavour
|
43.4 millimiter (mm)
Standard Deviation 30.25
|
44.6 millimiter (mm)
Standard Deviation 32.18
|
50.3 millimiter (mm)
Standard Deviation 32.24
|
46.1 millimiter (mm)
Standard Deviation 33.14
|
55.9 millimiter (mm)
Standard Deviation 31.20
|
20.1 millimiter (mm)
Standard Deviation 20.82
|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day 1, 0 Hour: Smell
|
60.7 millimiter (mm)
Standard Deviation 25.91
|
61.5 millimiter (mm)
Standard Deviation 24.57
|
47.5 millimiter (mm)
Standard Deviation 33.64
|
51.1 millimiter (mm)
Standard Deviation 26.11
|
51.7 millimiter (mm)
Standard Deviation 29.65
|
29.4 millimiter (mm)
Standard Deviation 29.34
|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day 1, 0 Hour: Sweetness
|
47.3 millimiter (mm)
Standard Deviation 27.12
|
41.2 millimiter (mm)
Standard Deviation 32.55
|
51.4 millimiter (mm)
Standard Deviation 31.91
|
50.7 millimiter (mm)
Standard Deviation 33.02
|
61.6 millimiter (mm)
Standard Deviation 21.19
|
12.9 millimiter (mm)
Standard Deviation 21.31
|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day 1, 0 Hour: Overall liking
|
46.8 millimiter (mm)
Standard Deviation 32.29
|
51.3 millimiter (mm)
Standard Deviation 30.67
|
50.2 millimiter (mm)
Standard Deviation 33.93
|
40.7 millimiter (mm)
Standard Deviation 31.60
|
48.8 millimiter (mm)
Standard Deviation 30.24
|
13.7 millimiter (mm)
Standard Deviation 20.07
|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day 1, 2-5 Min After Medicine: Taste in Mouth
|
39.7 millimiter (mm)
Standard Deviation 31.34
|
44.9 millimiter (mm)
Standard Deviation 30.74
|
44.7 millimiter (mm)
Standard Deviation 31.23
|
35.0 millimiter (mm)
Standard Deviation 32.21
|
46.7 millimiter (mm)
Standard Deviation 31.29
|
14.4 millimiter (mm)
Standard Deviation 21.07
|
|
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Day1,2-5 Min After Medicine:Acceptable to Swallow
|
68.2 millimiter (mm)
Standard Deviation 30.90
|
62.5 millimiter (mm)
Standard Deviation 26.48
|
55.7 millimiter (mm)
Standard Deviation 33.16
|
39.9 millimiter (mm)
Standard Deviation 33.71
|
61.1 millimiter (mm)
Standard Deviation 31.51
|
23.1 millimiter (mm)
Standard Deviation 29.19
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (up to Day 32)Population: The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.
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.
Outcome measures
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=31 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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=32 Participants
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 Participants
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 Participants
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
Adverse Events
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment B: 40 mg/kg Cysticide Tablet After Meal
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: 40 mg/kg Test ODT-PZQ After Meal
n=31 participants at risk
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.
|
Treatment B: 40 mg/kg Cysticide Tablet After Meal
n=32 participants at risk
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.
|
Treatment C1: 20 mg/kg Test ODT-PZQ After Meal
n=15 participants at risk
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.
|
Treatment C2: 60 mg/kg Test ODT-PZQ After Meal
n=15 participants at risk
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.
|
Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal
n=14 participants at risk
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.
|
Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal
n=15 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Baseline up to end of treatment (up to Day 32)
|
3.1%
1/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
26.7%
4/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Baseline up to end of treatment (up to Day 32)
|
3.1%
1/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/31 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/32 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/31 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/32 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
13.3%
2/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Baseline up to end of treatment (up to Day 32)
|
3.1%
1/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
6.7%
1/15 • Baseline up to end of treatment (up to Day 32)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31 • Baseline up to end of treatment (up to Day 32)
|
3.1%
1/32 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/14 • Baseline up to end of treatment (up to Day 32)
|
0.00%
0/15 • Baseline up to end of treatment (up to Day 32)
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place