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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1224-9781 | Registry Identifier | WHO |
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The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.
The study will enroll approximately 120 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:
All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30 minutes following the beginning of a high-fat/high calorie breakfast of each treatment period.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 86 days. Participants will be contacted by phone call approximately 10 days after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 mg dexlansoprazole capsules manufactured at TOB | Drug | Dexlansoprazole delayed-release capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose | |
| AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose | |
| AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment
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Healthy participants were enrolled in this 2-part and 2-way crossover study to receive dexlansoprazole 30 milligram (mg) capsules manufactured by Takeda GmbH Plant Oranienburg (TOB) and 30 mg capsules manufactured by Takeda Pharmaceutical Company Ltd. (TPC) in Part 1 and dexlansoprazole 60 mg capsules by TOB and 60 mg capsules by TPC in Part 2.
Participants took part in the study at 1 investigative site in the United States from 10 January 2019 to 09 April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (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 (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (2 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2019 | Feb 21, 2020 |
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| 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. |
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| 30 mg dexlansoprazole capsules manufactured at TPC | Drug | Dexlansoprazole delayed-release capsules. |
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| 60 mg dexlansoprazole capsules manufactured at TOB | Drug | Dexlansoprazole delayed-release capsules. |
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| 60 mg dexlansoprazole capsules manufactured at TPC | Drug | Dexlansoprazole delayed-release capsules. |
|
| FG001 | Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (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 (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| FG002 | Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (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 (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| FG003 | Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (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 (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
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| NOT COMPLETED |
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| Washout Period (at Least 5 Days) |
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| Period 2 (2 Days) |
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| Follow-Up (12 Days) |
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The safety set included all participants who enrolled into the study and received at least one dose of the study drug(s).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Dexlansoprazole 30 mg TOB + Dexlansoprazole 30 mg TPC | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (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 (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| BG001 | Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (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 (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| BG002 | Part 2: Dexlansoprazole 60 mg TOB + Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (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 (reference), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| BG003 | Part 2: Dexlansoprazole 60 mg TPC + Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (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 (test), orally, once, after a high fat/calorie breakfast on Day 1 of Period 2. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | The pharmacokinetic (PK) evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose |
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| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole | The PK evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter(ng*hour/mL) | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose |
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| Primary | AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole | PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose |
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| Primary | AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole | PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | Day 1 pre-dose and at multiple time points (up to 24 hours) post dose |
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Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 37)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2. | 0 | 61 | 0 | 61 | 4 | 61 |
| EG001 | Part 1: Dexlansoprazole 30 mg TPC | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2. | 0 | 61 | 0 | 61 | 3 | 61 |
| EG002 | Part 2: Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Period 1 or 2. | 0 | 59 | 0 | 59 | 7 | 59 |
| EG003 | Part 2: Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2. | 0 | 59 | 0 | 59 | 5 | 59 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2019 | Feb 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Withdrawal by Subject |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Geometric LSM ratio | 1.0737 | 2-Sided | 90 | 1.0025 | 1.1501 | Equivalence | ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax. |
| Part 2: Dexlansoprazole 60 mg TPC |
Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2. |
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| OG003 |
| Part 2: Dexlansoprazole 60 mg TPC |
Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2. |
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| OG003 |
| Part 2: Dexlansoprazole 60 mg TPC |
Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Period 1 or 2. |
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