A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 11, 2019

Primary Completion Date

January 18, 2020

Study Completion Date

January 18, 2020

Conditions
Respiratory Tract Disorders
Interventions
DRUG

N-acetylcysteine (NAC)

Two ampoules of IMP (300 + 300 mg) corresponding to a total dose of 600 mg of NAC diluted in 10 mL of NaCl 0.9% sterile saline solution, will be administered by a 5-minute i.v. infusion.

Trial Locations (1)

Unknown

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Zambon SpA

INDUSTRY

NCT03881163 - A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers | Biotech Hunter | Biotech Hunter