Sublingual vs IV Atropine Bioavailability Study

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 4, 2020

Primary Completion Date

February 2, 2020

Study Completion Date

February 8, 2020

Conditions
Toxic Effect of Organophosphate and Carbamate Insecticides
Interventions
DRUG

Atropine Sulfate Ophthalmic Solution

Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactive ingredients include benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection, USP.

DRUG

Atropine Sulphate Injection

Atropine sulfate injection, USP, 8mg/20mL (0.4 mg per mL) is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg; and may contain sulfuric acid for pH adjustment, pH 3.5 (3.0 to 3.8).

Trial Locations (1)

27265

High Point Clinical Trials Center, High Point

All Listed Sponsors
collaborator

Rho, Inc.

INDUSTRY

lead

Biomedical Advanced Research and Development Authority

FED

NCT04290039 - Sublingual vs IV Atropine Bioavailability Study | Biotech Hunter | Biotech Hunter