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NCT03131895 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT03131895: Completed Phase 1 study, sponsored by Takeda.
NCT03131895 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131895, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study 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).
Interventions
- DRUG 30 mg dexlansoprazole capsules manufactured at TOB
- DRUG 30 mg dexlansoprazole capsules manufactured at TPC
- DRUG 60 mg dexlansoprazole capsules manufactured at TOB
- DRUG 60 mg dexlansoprazole capsules manufactured at TPC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 1 |
What the finished NCT03131895 record still lists
NCT03131895 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 4 interventions - of which 30 mg dexlansoprazole capsules manufactured at TOB is the first listed.
NCT03131895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03131895 about?
NCT03131895 is a clinical study titled "Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants". 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...
What is the current status of trial NCT03131895?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2017-04-25. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT03131895?
The interventions under investigation include: 30 mg dexlansoprazole capsules manufactured at TOB (DRUG), 30 mg dexlansoprazole capsules manufactured at TPC (DRUG), 60 mg dexlansoprazole capsules manufactured at TOB (DRUG), 60 mg dexlansoprazole capsules manufactured at TPC (DRUG).
Who is sponsoring clinical trial NCT03131895?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03131895's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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