Trial · NCT02231918
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss). |
| Primary | Cmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss). |
| Primary | Cpre,N | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N). |
| Primary | Cavg | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Average concentration of the analyte in plasma at steady state (Cavg). |
| Primary | Tmax,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Time from dosing to maximum concentration at steady state (Tmax,ss). |
| Primary | Tmin,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Time from dosing to minimum concentration at steady state (Tmin,ss ). |
| Primary | AUCτ,ss | 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1. | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ). |
| Primary | λz,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Terminal rate constant in plasma at steady state (λz,ss ). |
| Primary | t1/2,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Terminal half-life of the analyte in plasma at steady state (t1/2,ss ). |
| Primary | MRTpo,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Mean residence time of the analyte in the body at steady state (MRTpo,ss). |
| Primary | CL/F,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ). |
| Primary | Vz/F,ss | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ). |
| Primary | Ae 0-12,ss | 12 hours after last study drug administration on day 1 | Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h). |
| Primary | fe 0-12,ss | 12 hours after last study drug administration on day 1. | Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ). |
| Primary | CLR,ss | 12h after last study drug administration on day 1 | Renal clearance of the analyte at steady state (CLR(0-12),ss ). |
| Primary | PTF | 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. | Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state. |
| Secondary | Number of Patients With Drug Related Adverse Events | From first drug administration until 24 hours after last study drug administration, upto 48 days | Number of patients with adverse events due to study drug. |
| Secondary | Vital Signs (Systolic and Diastolic Blood Pressure) | -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose. | Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)). |
| Secondary | Vital Signs (Pulse Rate) | -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h | Vital signs (Pulse rate (both supine and after standing for 1 minute)). |
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.
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