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dexlansoprazole manufactured at TOB · 2 trials · 1 indication
| 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 ...
Dexlansoprazole is a small molecule being studied in healthy volunteers. It is in Phase 1 clinical development for this purpose. The drug is being evaluated in clinical trials to assess its bioequivalence and bioavailability.
Dexlansoprazole is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers.
Dexlansoprazole is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers. Two Phase 1 trials have been completed, with a total of 238 participants enrolled.
Dexlansoprazole has two completed Phase 1 trials. NCT03131895 is a bioequivalence study of dexlansoprazole capsules from two manufacturing plants with 116 participants. NCT03801148 compares the bioavailability of dexlansoprazole delayed-release capsules with 122 participants. Both trials were conducted in the United States.
Dexlansoprazole is an investigational drug currently in Phase 1 clinical development. It is not approved for any use. The drug is being studied in healthy volunteers to evaluate its bioequivalence and bioavailability.