Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK587323 · 1 trial · 1 indication
PK parameters include: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-infinite\]) and area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC \[0-t\]). Twenty four blood samples (1x 5mililiter (mL)) will be collected at the specified time points for PK analysis of candesartan and HCTZ.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants in this arm will receive treatment A in period 1 and treatment B in period 2. Subjects will receive a single reference FDC tablet of 16mg candesartan cilexetil/12.5mg HCTZ as Treatment A administered orally with 240mL of water and a single 16mg candesartan cilexetil/12.5mg HCTZ FDC tablet (GSK587323) as Treatment B. |
| Sequence 2 | EXPERIMENTAL | Participants in this arm will receive treatment B in period 1 and treatment A in period 2. Subjects will receive a single reference FDC tablet of 16mg candesartan cilexetil/12.5mg HCTZ as Treatment A administered orally with 240mL of water and a single 16mg candesartan cilexetil/12.5mg HCTZ FDC tablet (GSK587323) as Treatment B. |
| Name | Type | Description |
|---|---|---|
| GSK587323 | DRUG | Single dose of FDC tablet formulation to be taken orally. |
| FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg | DRUG | Single dose of FDC tablet formulation to be taken orally |
Inclusion Criteria: * Subjects Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form * Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determin...
GSK587323 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GSK587323 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
GSK587323 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 16 participants. The drug is investigational and has not yet received regulatory approval for the treatment of hypertension.
GSK587323 has one completed Phase 1 clinical trial registered as NCT02094924, titled 'A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323'. The trial enrolled 16 participants in India and evaluated the drug in healthy volunteers.
GSK587323 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hypertension. The drug has completed one early-stage trial, but it remains under study and has not been authorized for commercial use.