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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03459911 | A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions | PHASE1 | COMPLETED | 66 | — | — | Feb 16, 2018 | Mar 16, 2018 | Nov 2, 2018 | 1 | India |
Peak Plasma Concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Losartan potassium 100 mg Tablets | EXPERIMENTAL | Losartan potassium is the test product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Losartan potassium. |
| Cozaar® (Losartan potassium)100 mg Tablets | ACTIVE_COMPARATOR | Cozaar® (Losartan potassium) is the reference product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Cozaar®. |
| Name | Type | Description |
|---|---|---|
| Cozaar 100mg Tablet | DRUG | Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands) |
| Losartan potassium 100mg | DRUG | Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus) |
Inclusion Criteria: The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study: 1. Healthy adult human subjects, aged between 18 to 45 years (both inclusive). 2. Subjects with Body Mass Index ...