Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Study primary Objective:
- To evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of
N-acetyl-cysteine 600 mg uncoated tablets vs. N-acetyl-cysteine 600 mg film-coated tablets
(NAC) in healthy male and female volunteers.
Study secondary objectives:
- To describe the pharmacokinetic (PK) profile of NAC in plasma after single dose
administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets;
- to collect safety and tolerability data after single dose administration of NAC 600 mg
uncoated tablets vs. NAC 600 mg film-coated tablets.