Tier 3 — preclinical

Pharmacokinetics and Safety of Single and Multiple Doses of Oral N-Acetylcysteine in Healthy Chinese and Caucasian Volunteers: An Open-Label, Phase I Clinical Study

Alberto Papi, Andrea F D Di Stefano, Milko Radicioni
Adv Ther 2021 38(1):468-478

Bibliography

PubMed
PMID 33146843
PubMed Central
PMC7854405
DOI
10.1007/s12325-020-01542-4
Funding
Funding disclosure was not located in the indexed record reviewed; consult the source publication for the full funding statement.
Competing interests
Competing-interest disclosure was not located in the indexed record reviewed; consult the source publication for the full declaration.

Study snapshot

DesignPhase I healthy-volunteer study
ModelHuman
Sample30 participants
Intervention600 mg oral NAC as a single dose followed by twice-daily dosing for 3 days
DurationSingle-dose plus 3-day multiple-dose phase
EndpointsPharmacokinetics; Ethnic comparison; Safety and tolerability

What the study showed, in plain terms

Modern Phase I study comparing oral NAC exposure and tolerability in Chinese and Caucasian healthy volunteers.

Key findings

Peak concentrations occurred rapidly and overall pharmacokinetic behavior was broadly similar between groups, with favorable short-term tolerability.

What this study can and cannot tell us

Short duration, healthy adults, and pharmacokinetic rather than efficacy endpoints.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology