Drug Safety Clinical Trial
Official title:
A Phase 1,Open, Dose-escalation Study to Assess the Efficacy and Safety of Fospropofol Disodium Injection in Healthy Volunteers
The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index [BIS]) and to compare the dynamic properties of PropofolF to those of Propofol.
After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01425502 -
Data-driven Quality Improvement in Primary Care - Trial
|
N/A | |
| Recruiting |
NCT01756183 -
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
|
Phase 2 | |
| Completed |
NCT01355016 -
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01757860 -
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01179854 -
Remegal Different Doses in Patients With Refractory Partial Seizures
|
Phase 2 | |
| Completed |
NCT00376415 -
A Safety Study of Lessertia Frutescens in Adults.
|
Phase 1 | |
| Active, not recruiting |
NCT01722916 -
Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase
|
Early Phase 1 | |
| Completed |
NCT01727778 -
Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01475097 -
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
|
Phase 4 | |
| Completed |
NCT01412658 -
Clinical Safety of a Novel Milk Protein Peptide
|
Phase 1 | |
| Terminated |
NCT01847222 -
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
|
Phase 1 | |
| Unknown status |
NCT01633099 -
Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients
|
Phase 3 | |
| Recruiting |
NCT01297842 -
Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
|
Phase 4 | |
| Completed |
NCT01284582 -
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)
|
Phase 1 | |
| Completed |
NCT01557270 -
Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery
|
Phase 3 | |
| Completed |
NCT01556607 -
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
|
Phase 1 | |
| Completed |
NCT01319903 -
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
|
Phase 1 | |
| Recruiting |
NCT04785027 -
Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT01428882 -
Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy
|
Phase 4 | |
| Completed |
NCT01367873 -
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
|
Phase 1 |