Sublingual Atropine Bioequivalence by Route of Administration (SABER) (SABER Trial)

Phase 1

Waitlist Available

Research Sponsored by Biomedical Advanced Research and Development Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (pre-dose), 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, and 240 minutes post-dose at days 1 and 8

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how the body absorbs and processes atropine when it is given as a single dose under the tongue or into the muscle in healthy adult volunteers.

Who is the study for?

This trial is for healthy adults who can safely receive atropine, a medication used in various treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

What is being tested?

The study is testing if the effects of atropine are the same when given under the tongue (sublingually) as when it's injected into a muscle (intramuscularly). It's set up so each person will try both methods in random order to compare them directly.

What are the potential side effects?

Atropine can cause dry mouth, blurred vision, sensitivity to light, lack of sweat production, increased heart rate, and potentially confusion or excitement especially in higher doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-dose), 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, and 240 minutes post-dose at days 1 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-dose), 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, and 240 minutes post-dose at days 1 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, and 240 minutes post-dose at days 1 and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf).

The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt).

Secondary study objectives

AUC120 - The relative bioavailability (plasma concentrations) of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 120 minutes (AUC120) on Day 1 and Day 8.

AUC150 - The relative bioavailability (plasma concentrations) of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 150 minutes (AUC150) on Day 1 and Day 8.

AUC240 - The relative bioavailability (plasma concentrations) of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 240 minutes (AUC240) on Day 1 and Day 8.

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