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Anticholinergic

Sublingual for Atropine bioequivalence (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 pre-dose through 8 hours post-dose at days 1 and 8

Awards & highlights

SABER Trial 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.Check my eligibility

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.See study design

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.

SABER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose through 8 hours post-dose at days 1 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose through 8 hours post-dose at days 1 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose through 8 hours post-dose at days 1 and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka)

The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2)

The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively)

+5 more

SABER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SublingualExperimental Treatment1 Intervention

1 mg (100 µL of a 1% w/v solution), administered SL by pipette with at least a 30 second dwell time without swallowing.

Group II: IntramuscularActive Control1 Intervention

Multidose vial presentation, 1 mg (2.5 ml) administered by IM injection into the mid-anterolateral thigh.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityLead Sponsor

83 Previous Clinical Trials

909,758 Total Patients Enrolled

Rho Federal Systems Division, Inc.Industry Sponsor

41 Previous Clinical Trials

13,575 Total Patients Enrolled

AllucentUNKNOWN

3 Previous Clinical Trials

257 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with the sublingual administration of this medication for patients?

"Our assessment at Power assigns a safety rating of 1 to Sublingual, as this is a Phase 1 trial with restricted evidence supporting both its safety and efficacy."

Answered by AI

Does the inclusion criteria of this medical study allow for participation by individuals aged 75 and above?

"Individuals aged above 18 years and under 65 years are eligible to participate in this clinical trial."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Information available on clinicaltrials.gov indicates that recruitment for this trial is presently closed. The trial was initially shared on April 15, 2024 and the latest update occurred on April 11, 2024. While participant enrollment is not ongoing currently in this study, there are other active trials seeking participants at this time."

Answered by AI

Is it possible for me to participate in this research study?

"Eligible participants for this research study must exhibit bioequivalence to atropine and fall within the age range of 18 to 65 years. The trial is currently seeking approximately 46 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sublingual Atropine Bioequivalence by Route of Administration (SABER)

2024. "Sublingual Atropine Bioequivalence by Route of Administration (SABER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06366087.