Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test formulation A · 1 trial · 1 indication
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Test followed by Reference Formulation | EXPERIMENTAL | Subjects will be randomized to receive single dose of Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 1 and Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods. |
| Reference followed by Test Formulation | EXPERIMENTAL | Subjects will be randomized to receive single dose of Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 1 and Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods. |
| Name | Type | Description |
|---|---|---|
| Test formulation A | DRUG | Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor. |
| Reference formulation B | DRUG | Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor. |
Inclusion Criteria: * Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination,...
A/turkey H5N1 vaccine is an investigational vaccine being developed for influenza. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to provide immunity against avian flu strains, as indicated by its clinical trial evaluating immunogenicity and safety in adults.
A/turkey H5N1 vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult populations.
A/turkey H5N1 vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not yet received regulatory approval. The Phase 2 trial, NCT00719043, has been completed and evaluated the vaccine's immunogenicity and safety in adults aged 18 years and older.
A/turkey H5N1 vaccine has one completed Phase 2 clinical trial, NCT00719043, titled 'Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years.' This trial enrolled 841 participants in the United States and Canada and included healthy volunteers.
Yes, A/turkey H5N1 vaccine is also known as 1557484A. The clinical trial NCT00719043 refers to the vaccine as 'GSK's Avian Flu Vaccine 1557484A,' confirming that 1557484A is an alternative name for the same investigational vaccine being developed by GSK.