Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATACAND · 1 trial · 1 indication
Pharmacokinetic parameters will be measured to estimate the relative bio-availability following administration of two candidate tablet formulations of Candesartan cilexetil relative to reference Candesartan cilexetil tablet. Pharmacokinetic parameters include: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinite\]), Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC\[0-t\]).
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment A in period 1, treatment B in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Sequence ACB | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment A in period 1, treatment C in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Sequence BAC | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment B in period 1, treatment A in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Sequence BCA | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment B in period 1, treatment C in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Sequence CAB | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment C in period 1, treatment A in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Sequence CBA | EXPERIMENTAL | Subjects in this arm will receive single dose of treatment C in period 1, treatment B in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. |
| Name | Type | Description |
|---|---|---|
| Candesartan Cilexetil in formulation 1 | DRUG | Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration |
| Candesartan Cilexetil in formulation 2 | DRUG | Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration |
| ATACAND | DRUG | Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration |
Inclusion Criteria: * Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory te...
ATACAND is a small molecule drug being developed for cardiovascular disease. It is currently in Phase 1 clinical development and is being studied as a treatment for conditions within the cardiovascular therapeutic area.
ATACAND is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK.
ATACAND is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for use. One Phase 1 clinical trial has been completed.
ATACAND has one completed Phase 1 clinical trial, identified as NCT02254447. This was a relative bioavailability study of candesartan cilexetil under fasting conditions, conducted in India with 18 healthy volunteers.
ATACAND is the brand name for the drug candesartan cilexetil. The completed clinical trial NCT02254447 studied the relative bioavailability of candesartan cilexetil, which is the active ingredient in ATACAND.