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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 manufactured at TOB refers to 30 mg dexlansoprazole delayed-release capsules produced at a specific manufacturing facility known as TOB. It is a small molecule developed by Takeda Pharmaceutical Company Limited (ticker: TAK). The product has been studied in Phase 1 clinical trials, primarily to compare its bioavailability and bioequivalence with capsules from other manufacturing plants.
Dexlansoprazole manufactured at TOB targets the ATP4A and ATP4B subunits of the gastric proton pump. It acts as an inhibitor of these targets. By inhibiting the proton pump, it reduces gastric acid secretion. This mechanism is characteristic of dexlansoprazole, a small molecule developed by Takeda Pharmaceutical Company Limited.
Dexlansoprazole manufactured at TOB is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical development of this specific manufacturing variant of dexlansoprazole.
Dexlansoprazole manufactured at TOB is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes two completed trials with a total enrollment of 238 participants, focused on bioavailability and bioequivalence in healthy volunteers.
Dexlansoprazole manufactured at TOB has been evaluated in two completed Phase 1 trials. NCT03801148 compared the bioavailability of dexlansoprazole delayed-release capsules in 122 healthy volunteers. NCT03131895 assessed bioequivalence of capsules from two manufacturing plants in 116 healthy volunteers. Both trials were conducted in the United States.