Approval Probability
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Also known as Fluimucil® 2% solution
Fluimucil 2% · 1 trial · 1 indication
AUC(0-last) of acetylcysteine will be calculated using trapezoidal rule. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Cmax of acetylcysteine will be obtained graphically from the plasma concentration over time profile. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
| Arm | Type | Description |
|---|---|---|
| Fluimucil® (reference) then Acetylcysteine (test) 2% solution | EXPERIMENTAL | Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Acetylcysteine (test). |
| Acetylcysteine (test) 2% solution then Fluimucil® (reference) | EXPERIMENTAL | Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Fluimucil® (reference). |
| Name | Type | Description |
|---|---|---|
| Fluimucil® 2% solution | DRUG | Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference). |
| Acetylcysteine 2% solution | DRUG | Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) |
Inclusion Criteria: * Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments. * Male and female participants of any ethnic origin between 18 and 45 years of age. Body ...
Fluimucil 2% is an acetylcysteine 2% oral solution developed by GSK plc. It is studied for infections of the respiratory tract. The product is a small molecule and is also written as Fluimucil® 2% solution. It has been evaluated in a Phase 1 bioequivalence study.
Fluimucil 2% is being studied for infections of the respiratory tract. Its only listed clinical trial enrolled healthy adult volunteers in Germany to compare the oral solution against a reference Fluimucil 2% oral solution, so the program is at the Phase 1 stage rather than in approved clinical use.
Fluimucil 2% is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor associated with the acetylcysteine 2% oral solution program for respiratory tract infections.
Fluimucil 2% is in Phase 1 development. Its single recorded trial, NCT02688361, is a completed Phase 1 bioequivalence study. The drug is investigational, and the available information does not indicate that it is FDA approved for any indication.
Fluimucil 2% has been studied in one completed Phase 1 trial, NCT02688361, titled A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution. It enrolled 46 healthy adult volunteers of all sexes in Germany, was randomized and controlled, and was not double blind.
Yes. Fluimucil 2% and Fluimucil® 2% solution refer to the same product, an acetylcysteine 2% oral solution developed by GSK plc. The registered trademark form of the name appears in the title of its Phase 1 bioequivalence trial, NCT02688361.