Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants
Condition: Healthy Volunteers
Intervention: 30 mg dexlansoprazole capsules manufactured at TOB; 30 mg dexlansoprazole capsules manufactured at TPC; 60 mg dexlansoprazole capsules manufactured at TOB; 60 mg dexlansoprazole capsules manufactured at TPC
Intervention description: Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

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).
    

Eligibility criteria:

        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.