Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 oral solution being studied for use in respiratory tract infections. It is a small molecule drug developed by GSK plc. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for any use.
Fluimucil 2% is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is a small molecule being investigated for respiratory tract infections. It is currently in Phase 1 clinical development.
Fluimucil 2% is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for respiratory tract infections, and one Phase 1 trial has been completed.
Fluimucil 2% has one completed Phase 1 clinical trial, identified as NCT02688361. This was a bioequivalence study comparing an acetylcysteine 2% oral solution to a reference Fluimucil 2% oral solution. The trial enrolled 46 participants in Germany and included healthy volunteers.
Fluimucil 2% is an oral solution containing acetylcysteine 2%. A completed Phase 1 trial, NCT02688361, was designed as a bioequivalence study comparing an acetylcysteine 2% oral solution to a reference Fluimucil 2% oral solution, indicating they are intended to be equivalent formulations.