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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01797926 | Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions | PHASE1 | COMPLETED | 102 | — | — | May 23, 2013 | Jul 25, 2013 | Jun 12, 2017 | 1 | South Africa |
Pharmacokinetic (PK) parameters for amlodipine and losartan will include the 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), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time exposure over the dosing and interval area under the plasma concentration time curve (AUC (0- infinity)), and maximum plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Group 1 (5 mg amlodipine and 50 mg losartan) | EXPERIMENTAL | Subjects in Group 1 will be randomized to receive a single dose FDC 5/50 mg tablet and also separate single tablets each of reference treatment 5 mg amlodipine and 50 mg losartan. The reference treatment will be replicated in a three sequence, three period design |
| Group 2 (5 mg amlodipine and 100 mg losartan) | EXPERIMENTAL | Subjects in Group 2 will be randomized to receive a single dose FDC 5/100 mg; and also separate single tablets each of reference treatment 5 mg amlodipine and 100 mg losartan. The reference treatment will be replicated in a three sequence, three period design |
| Name | Type | Description |
|---|---|---|
| Reference Treatment: 5 mg amlodipine + 50 mg losartan | DRUG | Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 50 mg losartan tablet administered orally in fasted state as a single dose |
| Reference Treatment:5 mg amlodipine + 100 mg losartan | DRUG | Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 100 mg losartan tablet administered orally in fasted state as a single dose |
| FDC 5/50 amlodipine/ losartan | DRUG | Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 50 mg losartan in fasted state |
| FDC 5/100 amlodipine /losartan | DRUG | Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 100 mg losartan in fasted state |
Inclusion Criteria: * Age \& Gender: Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>= 50 kg and body mass index (BMI) within the range 18.5 to 24.9 kilogram/meter squared. * Alanine aminotransferase (ALT) alkaline phosphatase an...