NCT02265224

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Zambon SpA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• no Condition

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-10-15
• Last updated: 2021-11-05
• Results posted: 2021-11-05