Human Volunteers Clinical Trial
Official title:
A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess the pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03093506 -
Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
|
Early Phase 1 | |
| Completed |
NCT00526968 -
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
|
Phase 1 | |
| Completed |
NCT03277456 -
A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1
|
Early Phase 1 | |
| Completed |
NCT02922933 -
A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01468714 -
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01452425 -
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
|
Phase 1 | |
| Completed |
NCT01464385 -
Nutrition Beverage Tolerance Study
|
Phase 2 | |
| Completed |
NCT02922946 -
Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat
|
Phase 1 | |
| Completed |
NCT00254449 -
Effect of NGX-4010 on ENFD and Sensory Function
|
Phase 1 | |
| Completed |
NCT01618903 -
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
|
Phase 1 | |
| Completed |
NCT00752466 -
A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately
|
Phase 1 | |
| Completed |
NCT00166933 -
Minimal Erythema Dose of UV-B in Normal Population of Taiwan
|
N/A | |
| Completed |
NCT05519514 -
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
|
Phase 1 | |
| Completed |
NCT01776437 -
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
|
Phase 1 | |
| Completed |
NCT01437033 -
Breath Test for Chemicals (Volatile Organic Compounds)
|
||
| Completed |
NCT01445860 -
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT00744809 -
TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.
|
Phase 1 | |
| Unknown status |
NCT00743977 -
Bioequivalence of Phenazopyridine HCl in Healthy Volunteers
|
N/A |