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NCT04290039 · ClinicalTrials.gov registry record · Phase 1
Sublingual vs IV Atropine Bioavailability Study
A Phase 1 study, sponsored by Biomedical Advanced Research and Development Authority.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04290039: Completed Phase 1 study, sponsored by Biomedical Advanced Research and Development Authority.
NCT04290039 is a Phase 1 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04290039, a Phase 1 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This randomized, three-sequence, three-period, phase 1 study is designed to assess the bioavailability and pharmacokinetics (PK) of sublingually administered atropine sulfate ophthalmic solution 1% USP (at 0.5 mg and 1.0 mg; test) compared to atropine sulfate injection administered IV (1.0 mg; reference).
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 2, 4, 6, 10, 15, 20, 30, 45, and 60 minutes, and 2, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using the noncompartmental method for extravascular (for sublingual doses) or IV infusion routes of administration. AUC\_∞ is summarized by study dosage as the geometric mean and coefficient of variation of the
Interventions
- DRUG Atropine Sulfate Ophthalmic Solution
- DRUG Atropine Sulphate Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-01-04 |
| Est. Completion | 2020-02-08 |
| Phase | Phase 1 |
What the finished NCT04290039 record still lists
NCT04290039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Atropine Sulfate Ophthalmic Solution is the first listed.
NCT04290039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04290039 about?
NCT04290039 is a clinical study titled "Sublingual vs IV Atropine Bioavailability Study". This randomized, three-sequence, three-period, phase 1 study is designed to assess the bioavailability and pharmacokinetics (PK) of sublingually administered atropine sulfate ophthalmic solution 1% USP (at 0.5 mg and 1.0 mg; test) compared to atropine sulfate injection administered IV (1.0 mg; refer...
What is the current status of trial NCT04290039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-01-04. Estimated completion is 2020-02-08.
What interventions are being tested in trial NCT04290039?
The interventions under investigation include: Atropine Sulfate Ophthalmic Solution (DRUG), Atropine Sulphate Injection (DRUG).
Who is sponsoring clinical trial NCT04290039?
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 NCT04290039's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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