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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1192-7711 | Registry Identifier | WHO | |
| CTR20160792 | Registry Identifier | SFDA |
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The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants.
The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
All participants will be asked to take single dose of study drug on Day 1.
This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
|
| Group 2: Dexlansoprazole 60 mg | Experimental | Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | Dexlansoprazole delayed-release capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple timepoints (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 timepoints (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 timepoints (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 |
|---|---|---|---|---|---|---|
| Phase I Clinical Trial Department | Beijing | Beijing Municipality | 100005 | China |
Healthy Chinese participants were enrolled in this two arm study to receive single oral dose of dexlansoprazole 30 and 60 milligram (mg) delayed-release capsules.
Participants took part in the study at 1 investigative site in China from 22 November 2017 to 08 February 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
| FG001 | Group 2: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
| BG001 | Group 2: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | The pharmacokinetics (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose |
|
Baseline up to 30 days after last dose (Day 31)
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 | Group 1: Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2018 | Feb 8, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 28, 2017 | Feb 8, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Height | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Mean | Standard Deviation | centimeter |
|
| Weight | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram |
|
| Body Mass Index (BMI) | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Classification | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Caffeine Consumption Status 72 hours Prior to Check-in (Day -1) | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Alcohol Consumption Status 7 Days Prior to Check-in (Day -1) | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Drug Abuse/Addiction | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Count of Participants | Participants |
|
|
|
| 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 measureable plasma concentration of dexlansoprazole. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose |
|
|
|
| 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 measureable plasma concentration of dexlansoprazole. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Group 2: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. | 0 | 20 | 0 | 20 | 1 | 20 |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| White blood cells urine | Investigations | MedDRA (20.0) | Systematic Assessment |
|
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.
| 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 |