Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

NCT03131895 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-390MR-1001U1111-1184-2186
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Part 1, Sequence 1 (Regimen A, B)

EXPERIMENTAL

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; Drug: 30 mg dexlansoprazole capsules manufactured at TPC

Part 1, Sequence 2 (Regimen B, A)

EXPERIMENTAL

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; Drug: 30 mg dexlansoprazole capsules manufactured at TPC

Part 2, Sequence 3 (Regimen C, D)

EXPERIMENTAL

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; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Part 2, Sequence 4 (Regimen D, C)

EXPERIMENTAL

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; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

Interventions

30 mg dexlansoprazole capsules manufactured at TOB DRUG

Dexlansoprazole delayed-release.

Part 1, Sequence 1 (Regimen A, B); Part 1, Sequence 2 (Regimen B, A)

30 mg dexlansoprazole capsules manufactured at TPC DRUG

Dexlansoprazole delayed-release.

Part 1, Sequence 1 (Regimen A, B); Part 1, Sequence 2 (Regimen B, A)

60 mg dexlansoprazole capsules manufactured at TOB DRUG

Dexlansoprazole delayed-release.

Part 2, Sequence 3 (Regimen C, D); Part 2, Sequence 4 (Regimen D, C)

60 mg dexlansoprazole capsules manufactured at TPC DRUG

Dexlansoprazole delayed-release.

Part 2, Sequence 3 (Regimen C, D); Part 2, Sequence 4 (Regimen D, C)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Who are capable of understanding and complying with protocol requirements.
• Must be in good health as determined by a physician based upon medical history, vital signs, electrocardiogram (ECG), and physical examination.
• 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.
• Must sign a written informed consent form (ICF) prior to initiation of study procedures.

You may not qualify if:

• 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).
• 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.
• Have received dexlansoprazole in a previous clinical study or as a therapeutic agent within 6 months of Screening,
• 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.
• Any significant results from physical examination or clinical laboratory results that make the participant unsuitable for the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

PRAHS Phase 1 unit

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: April 25, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 31, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Locations

US (1)