Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clop F1 · 1 trial · 1 indication
The following PK parameters were measured: area under the plasma concentration-time curve from time zero to infinity (AUC\[0 ∞\]), area under the plasma concentration-time curve from time zero to last time point with measurable concentration (AUC\[0 t\]) and maximum observed plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence A (Innovator) - B (Clop F1) - C (Clop F2) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 1, 75 mg tablet Clop F1 (Treatment B) in treatment period 2, and 75 mg tablet Clop F2 (Treatment C) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence A(Innovator) -C(Clop F2)-B (Clop F1) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 1, 75 mg tablet Clop F2 (Treatment C) in treatment period 2, and 75 mg tablet Clop F1 (Treatment B) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence B (Clop F1) - A (Innovator) - C (Clop F2) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F1 (Treatment B) in treatment period 1, 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 2, and 75 mg tablet Clop F2 (Treatment C) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence B (Clop F1) - C (Clop F2) - A (Innovator) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F1 (Treatment B) in treatment period 1, 75 mg tablet Clop F2 (Treatment C) in treatment period 2, and 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence C (Clop F2) - A (Innovator) - B (Clop F1) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F2 (Treatment C) in treatment period 1, 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 2, and 75 mg tablet Clop F1 (Treatment B) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence C (Clop F2) - B (Clop F1) - A (Innovator) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F2 (Treatment C) in treatment period 1, 75 mg tablet Clop F1 (Treatment B) in treatment period 2, and 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Name | Type | Description |
|---|---|---|
| Clop F1 | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
| Clop F2 | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
| Innovator | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
Inclusion Criteria: * Adult subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, la...
Clop F1 is an investigational small molecule being developed by GSK plc for cardiovascular disease. It is currently in Phase 1 clinical development, meaning it is still being studied in early-stage trials and is not yet approved for use.
Clop F1 is being studied for use in cardiovascular disease. It is an investigational drug, so its safety and efficacy are still being evaluated in clinical trials. It has not been approved by regulatory authorities for any indication.
Clop F1 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for cardiovascular disease.
Clop F1 is in Phase 1 clinical development. This is an early stage of testing, typically involving a small number of participants to assess safety and how the drug behaves in the body. The drug is investigational and not yet approved.
Clop F1 has one completed Phase 1 clinical trial, identified as NCT02502812. This was a bioequivalence study of clopidogrel 75 mg tablets in healthy subjects in India, with 18 participants. The trial was controlled but not double-blinded.
Clop F1 is being studied in a bioequivalence trial comparing clopidogrel 75 mg tablet formulations. The trial NCT02502812 evaluated Clop F1 against a reference tablet in healthy volunteers, indicating Clop F1 is being developed as a formulation related to clopidogrel.