An Exploratory Study to Evaluate the Efficacy and Safety of TYNADOTE® Combined N-acetylcysteine in the Treatment of Acetaminophen Overdose
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Poisoning and hospitalized patients taking acetaminophen.
• Acute ingestion of more than 150 mg/kg or plasma concentration of Acetaminophen is above the treatment line on single acute acetaminophen overdose nomogram.
• Male or female with age more than 20 years at Screening.
• Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments.
Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
ChengHuei Mr. Hsiong, Vice President
info@sinewpharma.com
+886-2-2788-5365
Backup
WanLing Ms. Yang, Research
wlyang@sinewpharma.com
+886-2-2788-5365
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Active_comparator: Test drug
200 mg/every 4 hours, with a loading dose (400 mg) and then followed by 17 maintenance doses
Placebo_comparator: Placebo
200 mg/every 4 hours, with a loading dose (400 mg) and then followed by 17 maintenance doses
Related Therapeutic Areas
Sponsors
Collaborators: Taipei Veterans General Hospital, Taiwan
Leads: Sinew Pharma Inc.