Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers

NCT02036775 ↗

Phase 1 Completed 24 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

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

Timeline

Start: 2014-03
Primary completion: 2014-05
Completion: 2014-05

Publications

Ollier C, Sent U, Mesquita M, Michel MC. Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan(R) Retard) Compared with Other Formulations in Healthy Volunteers. Pulm Ther. 2020 Jun;6(1):119-130. doi: 10.1007/s41030-020-00116-7. Epub 2020 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ambroxol	Small molecule	30 mg	Oral
Subject	Ambroxol	Small molecule	75 mg	Oral

Indications

No indication recorded.