Trial · NCT02325713
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | 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 | 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. | Hour*nanograms per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | hours | MEDIAN |
| SECONDARY | Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | hours | GEOMETRIC_MEAN |
| SECONDARY | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | hours | MEDIAN |
| SECONDARY | AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ | 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 | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | percentage of AUC0-inf | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | 1/h | GEOMETRIC_MEAN |
| SECONDARY | Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | percent bioavailability | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | Liter/hour | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | 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. | Liters | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ | 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 | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation | Baseline up to end of treatment (up to Day 32) | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | subjects | NUMBER |
| SECONDARY | Palatability Assessment Based on Visual Analog Scale (VAS) Score | Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | millimiter (mm) | MEAN |
| SECONDARY | Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters | Baseline up to end of treatment (up to Day 32) | The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments. | subjects | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02325713/outcomes