Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Detailed Description

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:

• Dexlansoprazole 30 mg TOB followed by Dexlansoprazole 30 mg TPC
• Dexlansoprazole 30 mg TPC followed by Dexlansoprazole 30 mg TOB
• Dexlansoprazole 60 mg TOB followed by Dexlansoprazole 60 mg TPC
• Dexlansoprazole 60 mg TPC followed by Dexlansoprazole 60 mg TOB

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • PRAHS Phase 1 unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy men and women aged 18 to 55 years old, inclusive, with a body mass index between 18 and 30 kilogram per square meter (kg/m^2), inclusive.
2. Who are capable of understanding and complying with protocol requirements.
3. Must be in good health as determined by a physician based upon medical history, vital signs, electrocardiogram (ECG), and physical examination.
4. Must have clinical chemistry, hematology, and complete urinalysis (after fasting for at least 8 hours) at Screening and Check-in (Day -1 of Period 1) results within the reference range for the testing laboratory unless the out-of-range results are deemed not clinically significant by the investigator.
5. Must sign a written informed consent form (ICF) prior to initiation of study procedures.

Exclusion Criteria:

1. Has a history of significant gastrointestinal (GI) disorders manifested with persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis (EE) with frequent [more than once per week] occurrence of heartburn).
2. Has consumed medications, certain foods, and supplements, including prescription and over-the-counter medications, within the protocol-specified time periods prior to Check-in (Day -1 of Period 1), or is unwilling to agree to abstain from these products.
3. Have received dexlansoprazole in a previous clinical study or as a therapeutic agent within 6 months of Screening,
4. Have a known hypersensitivity to any component of the formulation of dexlansoprazole capsules or other drugs with the same mechanism of action (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole), or related compounds.
5. Any significant results from physical examination or clinical laboratory results that make the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1, Sequence 1 (Regimen A, B); 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.	Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release.; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release.
EXPERIMENTAL: Part 1, Sequence 2 (Regimen B, A); 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.	Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release.; Drug: 30 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release.
EXPERIMENTAL: Part 2, Sequence 3 (Regimen C, D); 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.	Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release.; Drug: 60 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release.
EXPERIMENTAL: Part 2, Sequence 4 (Regimen D, C); 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.	Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Dexlansoprazole delayed-release.; Drug: 60 mg dexlansoprazole capsules manufactured at TPC; Dexlansoprazole delayed-release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ACTUAL): July 3, 2017
• Study Completion (ACTUAL): July 31, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: TAK-390MR-1001; U1111-1184-2186 (REGISTRY: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No