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NCT02723630 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02723630 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 60 participants.
The verdict
NCT02723630, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.
Interventions
- DRUG Lenvatinib 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02723630
The ClinicalTrials.gov registry entry for NCT02723630 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenvatinib 10 mg is the first listed.
NCT02723630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02723630 about?
NCT02723630 is a clinical study titled "Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers". This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.
What is the current status of trial NCT02723630?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2013-07. Estimated completion is 2013-08.
What interventions are being tested in trial NCT02723630?
The interventions under investigation include: Lenvatinib 10 mg (DRUG).
Who is sponsoring clinical trial NCT02723630?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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