Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366087
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-11
Brief Title:
Sublingual Atropine Bioequivalence by Route of Administration SABER
Sponsor:
Biomedical Advanced Research and Development Authority
Organization:
Biomedical Advanced Research and Development Authority
Study Overview
Official Title:
A Two-Period Two-Sequence Two-Treatment Single-Dose Crossover Study of Atropine Sulfate Ophthalmic Solution 1 Administered Sublingually vs Atropine Sulfate Administered Intramuscularly for Bioequivalence Determination
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABER
Brief Summary:
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
Detailed Description:
This is a randomized two-period two-sequence crossover study to assess the bioequivalence bioavailability and pharmacokinetics PK of a single dose of atropine administered SL or IM in healthy adult volunteers Approximately 46 healthy male and non-pregnant female volunteers will be enrolled to obtain approximately 36 evaluable participants in the per protocol population Additional participants may be randomized if participants are withdrawn prior to receiving one or both doses of study drug Eligible participants will be randomized at a 11 ratio to receive one of two treatment dosing sequences A Visit 1 SL Visit 2 IM or B Visit 1 IM Visit 2 SL
Volunteers will be screened for study participation from Days -14 to -3 After Screening on Day 1 eligible participants will be enrolled and will be randomized to receive dosing sequences A or B Once randomized each participant will receive 2 doses of atropine separated by a wash out period of 6 1 days During Visit 1 Day 1 and Visit 2 Day 8 participants will be administered SL or IM atropine according to their randomly assigned dosing sequence At each dosing visit blood samples for PK will be collected at time 0 pre-dose and at 13 time points post-dose at 5 10 15 20 30 45 60 and 90 minutes and 2 25 4 6 and 8 hours after dosing Participants will be discharged from the clinic after the 8-hour blood sample collection Participants will be followed for approximately 6 days after their last dose
Volunteers will be screened for study participation from Days -14 to -3 After Screening on Day 1 eligible participants will be enrolled and will be randomized to receive dosing sequences A or B Once randomized each participant will receive 2 doses of atropine separated by a wash out period of 6 1 days During Visit 1 Day 1 and Visit 2 Day 8 participants will be administered SL or IM atropine according to their randomly assigned dosing sequence At each dosing visit blood samples for PK will be collected at time 0 pre-dose and at 13 time points post-dose at 5 10 15 20 30 45 60 and 90 minutes and 2 25 4 6 and 8 hours after dosing Participants will be discharged from the clinic after the 8-hour blood sample collection Participants will be followed for approximately 6 days after their last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None