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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1189-8028 | Other Identifier | WHO | |
| 03083639 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.
The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in healthy participants in order to evaluate the bioequivalence between a single oral dose of esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:
All participants will be asked to take one capsule or tablet on Day 1 of each Intervention Period based on the treatment sequence to which the participant has been assigned.
This single center trial will be conducted in the United States. The overall duration to participate in this study is 36 days. Participants will visit the clinic on Day -1 and remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6 days will be maintained between the dose in each Intervention Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet | Experimental | Esomeprazole 40 mg, capsule, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg tablet, orally, once on Day 1 of Intervention Period 2. |
|
| Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule | Experimental | Esomeprazole 40 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg capsule, orally, once on Day 1 of Intervention Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole Capsule | Drug | Esomeprazole Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole | Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose | |
| AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole | Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose | |
| Cmax: Maximum Observed Plasma Concentration for Esomeprazole | Day 1 pre-dose and at multiple time points (up to 10 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 |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc. | Lenexa | Kansas | 66219 | United States |
Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences to receive esomeprazole 40 milligram (mg) capsule (Regimen A) or esomeprazole 40 mg tablet (Regimen B) under fasted conditions.
Participants took part in the study at 1 investigative site in the United States from 27 March 2017 to 13 May 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A + Regimen B | Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 2. |
| FG001 | Regimen B + Regimen A | Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (1 Day) |
| |||||||||||||
| Washout Period (at Least 6 Days) |
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| Intervention Period 2 (1 Day) |
|
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 | Regimen A + Regimen B | Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 2. |
| BG001 |
| 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 randomized 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 | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole | The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose |
|
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
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. The safety set where data was available for all participants who received at least one dose of Regimen A and Regimen B.
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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 | Regimen A | Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 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 | Jun 1, 2017 | Mar 15, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 7, 2017 | Mar 15, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| Esomeprazole Tablet | Drug | Esomeprazole Tablet |
|
|
| NOT COMPLETED |
|
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| NOT COMPLETED |
|
| Regimen B + Regimen A |
Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 2. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Region of Enrollment | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Weight | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram |
|
| Height | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | centimeter |
|
| Body Mass Index (BMI) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Status | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2. |
|
|
|
| Primary | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole | The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose |
|
|
|
|
| Primary | Cmax: Maximum Observed Plasma Concentration for Esomeprazole | The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 4 |
| 51 |
| EG001 | Regimen B | Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2. | 0 | 51 | 0 | 51 | 3 | 51 |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal 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.
| 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 |