A Study to Assess the Efficacy and Safety of Fospropofol Disodium

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271569
• Other study ID #: SFDA2009L09746
• Secondary ID: 2009L09746
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2011
• Last updated: January 5, 2011
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2010
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: the State Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• Fospropofol disodium
Fospropofol disodium: 0.5g

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS		2hr after administration	Yes
Secondary	Modified OAA/S Score		2hr after administration	Yes