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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02094924 | A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323 | PHASE1 | COMPLETED | 16 | — | — | Apr 17, 2014 | May 23, 2014 | May 15, 2017 | 1 | India |
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...