Phase 1
Completed N=116
Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03131895 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole — 515.7; 519.5; 1027.0; 978.6 nanogram/milliliter (ng/mL) — p=0.5535
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole |
515.7; 519.5; 1027.0; 978.6 | 0.5535 |
| PRIMARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole |
2416.3; 2327.6; 5715.5; 5684.7 | 0.3209 |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole |
2579.6; 2420.6; 5746.2; 5630.4 | 0.4163 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03131895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.