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NCT03341013 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03341013: Completed Phase 1 study, sponsored by MedImmune.
NCT03341013 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03341013, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
Primary Outcome
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
Interventions
- DRUG MEDI0382 Formulation 2
- DRUG MEDI0382 Formulation 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2018-01-29 |
| Phase | Phase 1 |
What the finished NCT03341013 record still lists
NCT03341013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which MEDI0382 Formulation 2 is the first listed.
NCT03341013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03341013 about?
NCT03341013 is a clinical study titled "A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382". This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized...
What is the current status of trial NCT03341013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-11-30. Estimated completion is 2018-01-29.
What interventions are being tested in trial NCT03341013?
The interventions under investigation include: MEDI0382 Formulation 2 (DRUG), MEDI0382 Formulation 3 (DRUG).
Who is sponsoring clinical trial NCT03341013?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03341013's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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