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The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg) Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in healthy male participants. Praziquantel (PZQ) is the active ingredient for Cisticid and Biltricide tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Cisticid, Then Biltricide, Then Biltricide | Experimental | Cisticid (Test) in Treatment Period 1 followed by Biltricide (Reference) in Treatment Period 2 and Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
|
| First Biltricide, Then Cisticid, Then Biltricide | Experimental | Biltricide (Reference) in Treatment Period 1 followed by Cisticid (Test) in Treatment Period 2 and then Biltricide (Reference) in Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
|
| First Biltricide, Then Biltricide, Then Cisticid | Experimental | Biltricide (Reference) in Treatment Period 1 and Treatment Period 2 followed by Cisticid (Test) in Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisticid | Drug | Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3). |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | The maximum observed plasma concentration of L-Praziquantel (L-PZQ). | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Time of the maximum drug concentration. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica de Enfermedades Crónicas y de Procedimientos Especiales, Sociedad Civil (SC) | México | 58249 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Cisticid, Then Biltricide, Then Biltricide | Participants received single oral dose of 1200 milligrams (mg) (two 600 mg tablets) Cisticid (Test) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Biltricide (Reference) on Day 8 in Treatment Period 2 and on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| FG001 | First Biltricide, Then Cisticid, Then Biltricide | Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 8 in Treatment Period 2 and then single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| FG002 | First Biltricide, Then Biltricide, Then Cisticid | Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 and on Day 8 in Treatment Period 2 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
|
All participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | First Cisticid, Then Biltricide, Then Biltricide | Participants received single oral dose of 1200 milligrams (mg) (two 600 mg tablets) Cisticid (Test) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Biltricide (Reference) on Day 8 in Treatment Period 2 and on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All participants who were randomized into the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration. | Pharmacokinetic (PK) analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and maximum observed plasma concentration (Cmax) in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Hour*nanogram per milliliter (h*ng/ml) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
|
Baseline up to Day 29
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisticid | All participants who received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2017 | Jul 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2019 | Jul 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Biltricide | Drug | Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
|
|
Time prior to the first measurable (non-zero) concentration; calculated as last time point at which the concentration is less than (<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration. |
| Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | AUC0-inf is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | AUCextra was reported in terms of percentage of AUC0-inf. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Lambda Z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd/f after oral dose was influenced by the fraction absorbed. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemate PZQ (Rac-PZQ) | Area under the drug plasma concentration-time curve from time zero to the time last measurable concentration. | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of Racemate PZQ (Rac-PZQ) | The maximum observed plasma concentration of rac-Praziquantel (rac-PZQ). | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant 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 study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. | Baseline up to Day 29 |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters were reported. Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. | Baseline up to Day 29 |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs were reported. Vital signs included body temperature, systolic / diastolic blood pressure, and pulse rate. | Baseline up to Day 29 |
| Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant abnormalities in 12-lead electrocardiogram (ECG) were reported. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. | Baseline up to Day 29 |
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| NOT COMPLETED |
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| BG001 | First Biltricide, Then Cisticid, Then Biltricide | Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 8 in Treatment Period 2 and then single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| BG002 | First Biltricide, Then Biltricide, Then Cisticid | Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 and on Day 8 in Treatment Period 2 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | All participants who were randomized into the study. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | All participants who were randomized into the study. | Count of Participants | Participants |
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| Race (NIH/OMB) | All participants who were randomized into the study. | Count of Participants | Participants |
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| OG001 | Biltricide First Administration | All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
| OG002 | Biltricide Second Administration | All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3). |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | The maximum observed plasma concentration of L-Praziquantel (L-PZQ). | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
|
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Time of the maximum drug concentration. | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Median | Full Range | hours | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
|
|
|
| Secondary | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Time prior to the first measurable (non-zero) concentration; calculated as last time point at which the concentration is less than (<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration. | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Median | Full Range | hours | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | AUC0-inf is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified category. | Posted | Mean | Standard Deviation | h*ng/ml | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | AUCextra was reported in terms of percentage of AUC0-inf. | PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified category. | Posted | Mean | Standard Deviation | Percentage of AUC0-inf | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified category. | Posted | Mean | Standard Deviation | hours | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Lambda Z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | PK analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Median | Full Range | Per hour | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified category. | Posted | Mean | Standard Deviation | Milliliter per hour | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd/f after oral dose was influenced by the fraction absorbed. | PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified category. | Posted | Mean | Standard Deviation | Milliliter | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemate PZQ (Rac-PZQ) | Area under the drug plasma concentration-time curve from time zero to the time last measurable concentration. | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | h*ng/ml | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Racemate PZQ (Rac-PZQ) | The maximum observed plasma concentration of rac-Praziquantel (rac-PZQ). | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose |
|
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant 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 study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. | Safety Analysis Set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters were reported. Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. | Safety Analysis Set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs were reported. Vital signs included body temperature, systolic / diastolic blood pressure, and pulse rate. | Safety Analysis Set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant abnormalities in 12-lead electrocardiogram (ECG) were reported. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. | Safety Analysis Set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Biltricide First Administration | All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). | 0 | 60 | 0 | 60 | 5 | 60 |
| EG002 | Biltricide Second Administration | All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3). | 0 | 60 | 0 | 60 | 6 | 60 |
| Headache | Nervous system disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA version 18.0 | Non-systematic Assessment |
|
| Alanine Transaminase Increased | Investigations | MedDRA version 18.0 | Non-systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
Not provided
Not provided
|
|
| Rac-PZQ |
|
|
| Rac-PZQ |
|
|
| Rac-PZQ |
|
|
| Rac-PZQ |
|
| Rac-PZQ |
|
|
| Rac-PZQ |
|
|
|