Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT03131895

Run by

Takeda

People needed

116

Starts

2017-04-25

Expected to finish

2017-07-31

Last updated by the study team

2019-06-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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