Trial · NCT04314037

Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide

NCT04314037, Phase 1, Completed, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany; results first posted 2021-08-13

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ConductScience Library. Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide. Trials, record NCT04314037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04314037

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
NCT number: NCT04314037
Status: Completed
Phases: Phase 1
Enrollment: 36 participants, actual
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions: Healthy
Interventions: Cesol (Test), Biltricide (Reference)
First posted: 2020-03-18
Last updated: 2021-08-13
Other registries' IDs: eudract:2019-002868-27
Results first posted: 2021-08-13

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Observed Plasma Concentration (Cmax) of Racemic-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 hours post-dose in each treatment period	Cmax was obtained directly from the concentration versus time curve.
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-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 hours post-dose in each treatment period	Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs	Baseline up to Day 27	Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: 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. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Baseline up to Day 27	Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
Secondary	Number of Participants With Clinically Relevant Changes From Baseline in Laboratory Parameters	Baseline up to Day 27	Laboratory investigation included hematology, biochemistry and urinalysis. Clinical relevance was determined by the investigator. The number of participants with clinically relevant changes from baseline in laboratory parameters were reported.
Secondary	Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs	Baseline up to Day 27	Vital signs included body temperature, systolic and diastolic blood pressure and pulse rate. Clinical relevance was determined by the investigator. The number of participants with clinically relevant changes from baseline in vital signs were reported.
Secondary	Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	Baseline up to Day 27	12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-Lead ECG findings were reported.
Secondary	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-(-)-PZQ and S-(+) 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 hours post-dose in each treatment period	Cmax was obtained directly from the concentration versus time curve.
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-(-)-PZQ and S-(+)-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 hours post-dose in each treatment period	Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Secondary	Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Racemic-Praziquantel (Rac-PZQ), R-(-)-PZQ and S-(+)-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 hours post-dose in each treatment period	AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Plasma Concentration (Cmax) of Racemic-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 hours post-dose in each treatment period	The Pharmacokinetic (PK) Analysis Set included all participants, who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.	nanogram per milliliter (ng/mL)	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-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 hours post-dose in each treatment period	The PK Analysis Set included all participants, who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.	hoursnanogram per milliliter (hng/mL)	GEOMETRIC_MEAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs	Baseline up to Day 27	The safety analysis set included all participants who were administered any dose of any study intervention.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Baseline up to Day 27	The safety analysis set included all participants who were administered any dose of any study intervention.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Relevant Changes From Baseline in Laboratory Parameters	Baseline up to Day 27	The safety analysis set included all participants who were administered any dose of any study intervention.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs	Baseline up to Day 27	The safety analysis set included all participants who were administered any dose of any study intervention.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	Baseline up to Day 27	The safety analysis set included all participants who were administered any dose of any study intervention.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-(-)-PZQ and S-(+) 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 hours post-dose in each treatment period	The PK Analysis Set included all participants, who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	GEOMETRIC_MEAN
SECONDARY	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-(-)-PZQ and S-(+)-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 hours post-dose in each treatment period	The PK Analysis Set included all participants, who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.	h*ng/mL	GEOMETRIC_MEAN
SECONDARY	Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Racemic-Praziquantel (Rac-PZQ), R-(-)-PZQ and S-(+)-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 hours post-dose in each treatment period	The PK Analysis Set included all participants, who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable for the specified category.	h*ng/mL	GEOMETRIC_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group140

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Observed Plasma Concentration (Cmax) of Racemic-Praziquantel (Rac-PZQ)	Cesol First Administration		421	Geometric Coefficient of Variation 118.3	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Racemic-Praziquantel (Rac-PZQ)	Cesol Second Administration		415	Geometric Coefficient of Variation 129.1	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Racemic-Praziquantel (Rac-PZQ)	Biltricide First Administration		425	Geometric Coefficient of Variation 98.3	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Racemic-Praziquantel (Rac-PZQ)	Biltricide Second Administration		459	Geometric Coefficient of Variation 129.5	nanogram per milliliter (ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-Praziquantel (Rac-PZQ)	Cesol First Administration		894	Geometric Coefficient of Variation 114.6	hoursnanogram per milliliter (hng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-Praziquantel (Rac-PZQ)	Cesol Second Administration		873	Geometric Coefficient of Variation 118.9	hoursnanogram per milliliter (hng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-Praziquantel (Rac-PZQ)	Biltricide First Administration		886	Geometric Coefficient of Variation 105.7	hoursnanogram per milliliter (hng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemic-Praziquantel (Rac-PZQ)	Biltricide Second Administration		964	Geometric Coefficient of Variation 124.8	hoursnanogram per milliliter (hng/mL)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs	Cesol First Administration	TEAEs	6		Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs	Cesol Second Administration	TEAEs	6		Participants

1 to 10 of 140Source ClinicalTrials.gov

See all 140 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period 1	STARTED	First Cesol, Then Biltricide, Then Cesol and Then Biltricide	18
Treatment Period 1	STARTED	First Biltricide, Then Cesol, Then Biltricide and Then Cesol	18
Treatment Period 1	COMPLETED	First Cesol, Then Biltricide, Then Cesol and Then Biltricide	18
Treatment Period 1	COMPLETED	First Biltricide, Then Cesol, Then Biltricide and Then Cesol	18
Treatment Period 1	NOT COMPLETED	First Cesol, Then Biltricide, Then Cesol and Then Biltricide	0
Treatment Period 1	NOT COMPLETED	First Biltricide, Then Cesol, Then Biltricide and Then Cesol	0
Treatment Period 2	STARTED	First Cesol, Then Biltricide, Then Cesol and Then Biltricide	18
Treatment Period 2	STARTED	First Biltricide, Then Cesol, Then Biltricide and Then Cesol	18
Treatment Period 2	COMPLETED	First Cesol, Then Biltricide, Then Cesol and Then Biltricide	17
Treatment Period 2	COMPLETED	First Biltricide, Then Cesol, Then Biltricide and Then Cesol	18

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Cesol First Administration	0	36
other	Abdominal pain upper	Gastrointestinal disorders	Cesol Second Administration	0	34
other	Abdominal pain upper	Gastrointestinal disorders	Biltricide First Administration	1	36
other	Abdominal pain upper	Gastrointestinal disorders	Biltricide Second Administration	0	34
other	Diarrhoea	Gastrointestinal disorders	Cesol First Administration	1	36
other	Diarrhoea	Gastrointestinal disorders	Cesol Second Administration	0	34
other	Diarrhoea	Gastrointestinal disorders	Biltricide First Administration	1	36
other	Diarrhoea	Gastrointestinal disorders	Biltricide Second Administration	0	34
other	Dyspepsia	Gastrointestinal disorders	Cesol First Administration	0	36
other	Dyspepsia	Gastrointestinal disorders	Cesol Second Administration	1	34

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cesol First Administration	0	36
Total, all-cause mortality	Cesol Second Administration	0	34
Total, all-cause mortality	Biltricide First Administration	0	36
Total, all-cause mortality	Biltricide Second Administration	0	34
Total, other adverse events	Cesol First Administration	6	36
Total, other adverse events	Cesol Second Administration	6	34
Total, other adverse events	Biltricide First Administration	7	36
Total, other adverse events	Biltricide Second Administration	7	34
Total, serious adverse events	Cesol First Administration	0	36
Total, serious adverse events	Cesol Second Administration	0	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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