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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03801148 | A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules | PHASE1 | COMPLETED | 122 | — | — | Jan 10, 2019 | Apr 9, 2019 | Mar 19, 2020 | 1 | United States |
| NCT03131895 | Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants | PHASE1 | COMPLETED | 116 | — | — | Apr 25, 2017 | Jul 31, 2017 | Jun 14, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC) | EXPERIMENTAL | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB) | EXPERIMENTAL | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC) | EXPERIMENTAL | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB) | EXPERIMENTAL | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 1, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C \[test\]), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| Part 1, Sequence 1 (Regimen A, B) | EXPERIMENTAL | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once on Day 1 of Period 2 following a 10-hour fast. |
| Part 1, Sequence 2 (Regimen B, A) | EXPERIMENTAL | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B \[reference\]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A \[test\]), orally, once on Day 1 of Period 2 following a 10-hour fast. |
| Part 2, Sequence 3 (Regimen C, D) | EXPERIMENTAL | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C \[test\]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once on Day 1 of Period 2 following a 10-hour fast. |
| Part 2, Sequence 4 (Regimen D, C) | EXPERIMENTAL | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D \[reference\]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regiment C \[test\]), orally, once on Day 1 of Period 2 following a 10-hour fast. |
| Name | Type | Description |
|---|---|---|
| 30 mg dexlansoprazole capsules manufactured at TOB | DRUG | Dexlansoprazole delayed-release capsules. |
| 30 mg dexlansoprazole capsules manufactured at TPC | DRUG | Dexlansoprazole delayed-release capsules. |
| 60 mg dexlansoprazole capsules manufactured at TOB | DRUG | Dexlansoprazole delayed-release capsules. |
| 60 mg dexlansoprazole capsules manufactured at TPC | DRUG | Dexlansoprazole delayed-release capsules. |
Inclusion Criteria: 1. Has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m\^2), at Screening. 2. Is willing and able to consume the high-fat/high-calorie breakfast administered during the study. Exclusion Criteria: 1. Has a history of drug abuse (defined as any illicit drug ...