Trial Outcomes & Findings for A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants (NCT NCT03083639)

NCT ID: NCT03083639

Last Updated: 2019-06-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

52 participants

Primary outcome timeframe

Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Results posted on

2019-06-14

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 27 March 2017 to 13 May 2017.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Intervention Period 1 (1 Day) STARTED	26	26
Intervention Period 1 (1 Day) COMPLETED	26	26
Intervention Period 1 (1 Day) NOT COMPLETED	0	0
Washout Period (at Least 6 Days) STARTED	26	26
Washout Period (at Least 6 Days) COMPLETED	25	25
Washout Period (at Least 6 Days) NOT COMPLETED	1	1
Intervention Period 2 (1 Day) STARTED	25	25
Intervention Period 2 (1 Day) COMPLETED	25	25
Intervention Period 2 (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Washout Period (at Least 6 Days) Pregnancy	0	1
Washout Period (at Least 6 Days) Lost to Follow-up	1	0

Baseline Characteristics

The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Regimen A n=51 Participants Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.	Regimen B n=49 Participants Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole	1908.0 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 66.0	1922.2 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 57.9

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Regimen A n=51 Participants Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.	Regimen B n=51 Participants Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole	1884.6 h*ng/mL Geometric Coefficient of Variation 64.3	1882.6 h*ng/mL Geometric Coefficient of Variation 57.5

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Outcome measures

Outcome measures
Measure	Regimen A n=51 Participants Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.	Regimen B n=51 Participants Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
Cmax: Maximum Observed Plasma Concentration for Esomeprazole	933.29 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 44.5	872.38 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 43.5

Adverse Events

Regimen A

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Regimen B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regimen A n=51 participants at risk Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.	Regimen B n=51 participants at risk Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
Nervous system disorders Headache	5.9% 3/51 • 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.	3.9% 2/51 • 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.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/51 • 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.	2.0% 1/51 • 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.0% 1/51 • 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.	2.0% 1/51 • 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Regimen A + Regimen B n=26 Participants 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.	Regimen B + Regimen A n=26 Participants 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.	Total n=52 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 9.64 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	33.3 years STANDARD_DEVIATION 7.83 • n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	32.8 years STANDARD_DEVIATION 8.71 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Sex: Female, Male Female	9 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	11 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	20 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Sex: Female, Male Male	17 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	15 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	32 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	11 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	19 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) White	18 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	13 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	31 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Region of Enrollment United States	26 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	26 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	52 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Weight	73.3 kilogram STANDARD_DEVIATION 12.83 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	75.3 kilogram STANDARD_DEVIATION 13.37 • n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	74.3 kilogram STANDARD_DEVIATION 13.01 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Height	173.4 centimeter STANDARD_DEVIATION 10.36 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	170.7 centimeter STANDARD_DEVIATION 10.95 • n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	172.0 centimeter STANDARD_DEVIATION 10.65 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Body Mass Index (BMI)	24.3 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.77 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	25.7 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.89 • n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	25.0 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.89 • n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Smoking Status Never smoked	18 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	24 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	42 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Smoking Status Ex-smoker	8 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=7 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	10 Participants n=5 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.