Pharmacokinetic Clinical Trial
Official title:
A Pharmacokinetic Study of PLENVU® in Healthy Subjects
This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.
PLENVU is a novel, low volume (1 L) PEG 3350 and ascorbate based bowel preparation that has been developed to provide whole bowel cleansing. Studies have shown that formulating the osmotically active agents sodium ascorbate/ascorbic acid (also known as vitamin C) and sodium sulfate in combination with PEG 3350 enable a reduction in the volume of the PEG-based lavage solution. PLENVU has a dual formulation containing an initial majority PEG dose followed by a majority ascorbate dose to maximise the overall effectiveness. This novel formulation addresses the challenges faced by patients to comply with drinking higher volume, 2 and 3 L, preparations. The purpose of this study is to determine if there is systemic exposure to components of the PLENVU formulation (PEG 3350, ascorbate and potential related substances/metabolites (oxalic acid, glycolic acid, ethylene glycol and diethylene glycol). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04531150 -
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
|
Phase 1 | |
| Completed |
NCT03979989 -
Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)
|
Phase 1 | |
| Completed |
NCT00743912 -
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05367011 -
Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU
|
||
| Completed |
NCT06126562 -
A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00745264 -
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
|
Phase 1 | |
| Completed |
NCT03344627 -
Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
|
N/A | |
| Completed |
NCT01082796 -
Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects
|
N/A | |
| Terminated |
NCT02696954 -
Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03714568 -
Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.
|
Phase 1 | |
| Recruiting |
NCT04080895 -
Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT04735913 -
Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults
|
Early Phase 1 | |
| Completed |
NCT03011996 -
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
|
Phase 1 | |
| Completed |
NCT00681395 -
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
|
Phase 1 | |
| Completed |
NCT04617509 -
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
|
Phase 1 | |
| Terminated |
NCT03059511 -
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
|
Phase 1 | |
| Withdrawn |
NCT05938608 -
A Study to Assess the Availability of Oral Primaquine and Its Inert Metabolite, Carboxyprimaquine, in the Body
|
Phase 1 | |
| Completed |
NCT01091532 -
A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
|
Phase 1 | |
| Completed |
NCT03951402 -
Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT03882762 -
A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol
|
Phase 1 |