Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

Launched by TAKEDA · Apr 24, 2017

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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.