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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1184-2186 | Registry Identifier | WHO |
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The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).
The drug being tested in this study is called dexlansoprazole. This study will compare bioavailability of dexlansoprazole from 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TOB relative to the corresponding 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TPC. The study will enroll approximately 104 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatment sequences:
All participants will be asked to take single oral dose of dexlansoprazole at the same time on Day 1 of each Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 18 days. Participants will visit the clinic on Day -1 and remained confined until Day 2 of Period 1 and 2. A washout period of minimum 5 days will be maintained between the doses in each Period. Participants will be contacted by telephone 10 (+/-2) days after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 mg dexlansoprazole capsules manufactured at TOB | Drug | Dexlansoprazole delayed-release. |
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| 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 | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity 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 |
|---|---|---|---|---|---|---|
| PRAHS Phase 1 unit | Salt Lake City | Utah | 84106 | United States |
Healthy participants were enrolled in this 2 part study to receive dexlansoprazole 30 milligram (mg) capsules manufactured by Takeda GmbH Plant (Oranienburg, Germany) (TOB) or 30 mg capsules manufactured by Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC) in Part 1 and dexlansoprazole 60 mg capsules by TOB or 60 mg capsules by TPC in Part 2.
Participants took part in the study at 1 investigative site in the United States from 25 April 2017 to 31 July 2017.
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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 on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention 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 | Jun 6, 2017 | Mar 15, 2019 |
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| 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. |
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| 30 mg dexlansoprazole capsules manufactured at TPC | Drug | Dexlansoprazole delayed-release. |
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| 60 mg dexlansoprazole capsules manufactured at TOB | Drug | Dexlansoprazole delayed-release. |
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| 60 mg dexlansoprazole capsules manufactured at TPC | Drug | Dexlansoprazole delayed-release. |
|
| FG001 | Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| FG002 | Part 2: Dexlansoprazole 60 mg TOB+ Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| FG003 | Part 2: Dexlansoprazole 60 mg TPC+ Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
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| NOT COMPLETED |
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| Washout Period (at Least 5 Days) |
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| Intervention Period 2 (2 Days) |
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The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
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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 on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| BG001 | Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| BG002 | Part 2: Dexlansoprazole 60 mg TOB+ Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| BG003 | Part 2: Dexlansoprazole 60 mg TPC+ Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast. |
| 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, Continuous | Mean | Standard Deviation | Years |
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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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| Body mass index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking Classification | Number | participants |
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| Alcohol Classification | Number | participants |
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| Caffeine Consumption | Number | participants |
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| Xanthine Consumption | Number | 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) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | 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 set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | 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 | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole | The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. PK analysis set where data at specified time points was available. | Posted | Mean | Standard Deviation | 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 | Dexlansoprazole 30 mg TOB | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2. | 0 | 51 | 0 | 51 | 8 | 51 |
| EG001 | Dexlansoprazole 30 mg TPC | Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2. | 0 | 55 | 0 | 55 | 9 | 55 |
| EG002 | Dexlansoprazole 60 mg TOB | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2. | 0 | 55 | 0 | 55 | 8 | 55 |
| EG003 | Dexlansoprazole 60 mg TPC | Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2. | 0 | 56 | 0 | 56 | 11 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Injection site erosion | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA (20.0) | 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 | Jun 28, 2017 | Mar 15, 2019 | 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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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Other |
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| Withdrawal by Subject |
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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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| Former Smoker |
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| Current Smoker |
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| Former Drinker |
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| Current Drinker |
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| Had no caffeine consumption |
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| Had no xanthine consumption |
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| ANOVA | 0.8920 | LS mean ratio | 1.0185 | 2-Sided | 90 | 0.9334 | 1.1113 | Equivalence | A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale. |
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