To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers

Phase 1 Completed 28 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.

Timeline

Start: 2018-03-01
Primary completion: 2018-03-29
Completion: 2018-03-29

Publications

Mallefet P, Armogida M, Doll WJ, Page RC, Sandefer EP. A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers. Trials. 2022 Feb 8;23(1):128. doi: 10.1186/s13063-022-06037-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	325 mg	Oral
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Dextromethorphan	Unknown	10 mg	Oral
Subject	Dextromethorphan	Unknown	20 mg	Oral
Subject	Phenylephrine	Small molecule	5 mg	Oral
Subject	Phenylephrine	Small molecule	10 mg	Oral

To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers

Summary

Timeline

Publications

Drugs

Indications