CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
N-acetylcysteinedrug
Likely dose
N-acetylcysteine 150 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02265224
NCT02265224Phase 1Completed
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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

Zambon SpA·interventional·Posted Oct 15, 2014·Updated Nov 5, 2021

In Brief

A Phase 1 clinical trial evaluating N-acetylcysteine for no Condition. Completed, enrolled 48 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Conditionsno Condition
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 15, 2014
Enrollment StartSep 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.7 years ago

Interventions

N-acetylcysteinedrug

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.