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NCT02821338 · ClinicalTrials.gov registry record · Phase 1
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02821338 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 30 participants.
The verdict
NCT02821338, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.
Interventions
- DRUG Lamotrigine Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02821338
The ClinicalTrials.gov registry entry for NCT02821338 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lamotrigine Extended Release is the first listed.
NCT02821338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02821338 about?
NCT02821338 is a clinical study titled "A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects". The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.
What is the current status of trial NCT02821338?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-06. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02821338?
The interventions under investigation include: Lamotrigine Extended Release (DRUG).
Who is sponsoring clinical trial NCT02821338?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
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