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This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants. Eligible participants will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N- acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution, 200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in each period. After completion of the second study period (i.e. last pharmacokinetic (PK) sample on Day 3 of Period 2) participants will be discharged from the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluimucil® 2% solution | Drug | Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to last sampling time [AUC(0-last)] | 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. | 3 days |
| Maximum Plasma Concentration (Cmax) | 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to infinity [AUC(0-inf.)] | AUC(0-inf.) 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. | 3 days |
| Time to reach maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Erfurt | Thuringia | 99084 | Germany |
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| Label | URL |
|---|---|
| Results for Study 205033 can be found on the GSK Clinical Study Register | View source |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Acetylcysteine 2% solution | Drug | Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) |
|
Tmax 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. |
| 3 days |
| Termination rate constant (Lambda_z) | Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time. | 3 days |
| Residual Area (RA) | RA will be calculated as percent extrapolated area (= (AUCinf - AUClast)/ AUCinf)*100%). | 3 days |
| Elimination half life (t1/2) | T1/2 will be computed as T1/2 = 0.693/ λz | 3 days |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004364 | Pharmaceutical Preparations |