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Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)

no Condition Clinical Trial

Official title:
Comparative Bioavailability Study of N-acetyl-cysteine (NAC) 600 mg Uncoated Tablets vs. NAC 600 mg Film-coated Tablets in Healthy Male and Female Volunteers

Clinical Trial 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.

Clinical Trial Description

This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence study to compare two different oral formulations of NAC. The study has been conducted in healthy volunteers of both genders, in one single dose of both formulations. The initial 48 subjects were sufficient to satisfy the study objectives on the basis of the ad interim preliminary bioequivalence test. The study was then considered as concluded and the second stage did not take place. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02265224
Study type Interventional
Source Zambon SpA
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date September 2014
View Details
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