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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: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT02821338 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pre-dose, and post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours Lamotrigine and Lamictal have the same active ingredient "Lamotrigine."
Interventions
- DRUG Lamotrigine Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
What the finished NCT02821338 record still lists
NCT02821338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Lamotrigine Extended Release is the first listed.
NCT02821338 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02821338's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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