Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03408392 | Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Feb 6, 2018 | Mar 13, 2018 | Feb 25, 2020 | 1 | South Africa |
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,...