A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules

NCT ID: NCT03801148

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2019-04-09

Brief Summary

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.).

Detailed Description

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:

• Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)
• Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)
• Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)
• Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1:Dexlansoprazole 30mg (TOB) + Dexlansoprazole 30mg (TPC)

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.

Group Type: EXPERIMENTAL

30 mg dexlansoprazole capsules manufactured at TOB

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

30 mg dexlansoprazole capsules manufactured at TPC

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

Part 1:Dexlansoprazole 30mg (TPC) + Dexlansoprazole 30mg (TOB)

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.

Group Type: EXPERIMENTAL

30 mg dexlansoprazole capsules manufactured at TOB

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

30 mg dexlansoprazole capsules manufactured at TPC

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

Part 2:Dexlansoprazole 60mg (TOB) + Dexlansoprazole 60mg (TPC)

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.

Group Type: EXPERIMENTAL

60 mg dexlansoprazole capsules manufactured at TOB

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

60 mg dexlansoprazole capsules manufactured at TPC

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

Part 2:Dexlansoprazole 60mg (TPC) + Dexlansoprazole 60mg (TOB)

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.

Group Type: EXPERIMENTAL

60 mg dexlansoprazole capsules manufactured at TOB

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

60 mg dexlansoprazole capsules manufactured at TPC

Intervention Type: DRUG

Dexlansoprazole delayed-release capsules.

Interventions

30 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release capsules.

Intervention Type: DRUG

30 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release capsules.

Intervention Type: DRUG

60 mg dexlansoprazole capsules manufactured at TOB

Dexlansoprazole delayed-release capsules.

Intervention Type: DRUG

60 mg dexlansoprazole capsules manufactured at TPC

Dexlansoprazole delayed-release capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m^2), at Screening.

2. Is willing and able to consume the high-fat/high-calorie breakfast administered during the study.

Exclusion Criteria

1. Has a history of drug abuse (defined as any illicit drug use) or drug addiction in the 12 months prior to Screening or a history of alcohol abuse (defined as regular consumption exceeding 21 units per week [1 unit equal (=) 12 ounces (oz) beer, 1.5 oz hard liquor, or 5 oz wine]) within 1 year prior to the Screening Visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study.

2. Has a positive test result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Check-in (Day -1 of Period 1).

3. Has received any known hepatic or renal clearance altering agents (example, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc) for a period of 28 days prior to Day 1 of Period 1.

4. Has donated blood products (such as plasma) within 30 days or has donated whole blood or lost 450 milliliter (mL) or more of his or her blood volume, or had a transfusion of any blood product within 56 days prior to Day 1 of Period 1.

5. With the exception of acetaminophen, the subject has taken any excluded medication, supplements, or food products or beverages containing grapefruit or grapefruit juice, star fruit or star fruit juice, Seville-type (sour) oranges and marmalade, apple, orange, or pineapple juice, vegetables from the mustard green family (example, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats. Hormonal contraception and hormone replacement therapy are allowed, as long as the subject has been on a stable dose for a minimum of 90 days prior to Day 1 of Period 1.

6. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch nicotine gum, e-cigarettes) within 28 days prior to Check-in (Day -1 of Period 1), or has a positive cotinine test at Screening or Check-in (Day -1 of Period 1), or is unwilling to abstain from these products for the duration of the study.

7. Has received dexlansoprazole or lansoprazole in a previous clinical study or as a therapeutic agent within 6 months of screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1224-9781

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-390MR-1002

Identifier Type: -

Identifier Source: org_study_id