At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomised, Multiple-dose, Three-period Crossover Study in Healthy Male and Female Volunteers to Characterise Pharmacokinetics and Assess the Relative Bioavailability of Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolonged-release Hard Capsules 75 mg and Lasolvan® Effervescent Tablets 60 mg Compared to Lasolvan® Tablets 30 mg.
In Brief
A Phase 1 clinical trial evaluating Lasolvan tablet, Lasolvan effervescent tablet, and 2 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To characterise pharmacokinetics and assess the relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg
Study Details
Timeline
Interventions
One Lasolvan tablet 30 mg twice daily for 5 days.
One Lasolvan tablet 30 mg twice daily for 5 days.
One Lasolvan tablet 30 mg twice daily for 5 days.
One Lasolvan tablet 30 mg twice daily for 5 days.
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One Lasolvan tablet 30 mg twice daily for 5 days.
One Lasolvan tablet 30 mg twice daily for 5 days.
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.