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NCT06366087 · ClinicalTrials.gov registry record · Phase 1
Sublingual Atropine Bioequivalence by Route of Administration (SABER)
A Phase 1 study, sponsored by Biomedical Advanced Research and Development Authority.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT06366087: Completed Phase 1 study, sponsored by Biomedical Advanced Research and Development Authority.
NCT06366087 is a Phase 1 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06366087, a Phase 1 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers.
Primary Outcome
Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and route using noncompartmental analysis (NCA) methods. AUCinf is summarized by route of administration as the geometric mean and coefficient of variation of the geometric mean for all evaluable participants and express
Interventions
- DRUG Atropine Sulfate Ophthalmic Solution USP, 1%
- DRUG Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-04-15 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 1 |
What the finished NCT06366087 record still lists
NCT06366087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Atropine Sulfate Ophthalmic Solution USP, 1% is the first listed.
NCT06366087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06366087 about?
NCT06366087 is a clinical study titled "Sublingual Atropine Bioequivalence by Route of Administration (SABER)". A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers.
What is the current status of trial NCT06366087?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2024-04-15. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT06366087?
The interventions under investigation include: Atropine Sulfate Ophthalmic Solution USP, 1% (DRUG), Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) (DRUG).
Who is sponsoring clinical trial NCT06366087?
This trial is sponsored by Biomedical Advanced Research and Development Authority, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06366087's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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