protocolSection identificationModule nctId: NCT06366087, orgStudyIdInfo id: BP-C-24-001, briefTitle: Sublingual Atropine Bioequivalence by Route of Administration (SABER), acronym: SABER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2024-05-24, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Biomedical Advanced Research and Development Authority, class: FED, collaborators name: Rho Federal Systems Division, Inc., collaborators name: Allucent, descriptionModule briefSummary: 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., conditionsModule conditions: Atropine Bioequivalence, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Atropine Sulfate Ophthalmic Solution USP, 1%, interventions name: Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL), outcomesModule primaryOutcomes measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf)., primaryOutcomes measure: 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)., secondaryOutcomes measure: 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), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johnson County Clin-Trials (JCCT), city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: Carlos A Fierro, MD, role: CONTACT, phone: 913-825-4400, email: cfierro@jcct.com, contacts name: Mazen Zari, role: CONTACT, phone: 913-825-4400, email: mzari@jcct.com, contacts name: Carlos A Fierro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False