Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205407
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-01-02
Brief Title:
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites Viatris and Neolpharma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Single-dose Open-label Randomized 2-way Cross-over Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer From Viatris to Neolpharma for SpironolactoneHydrochlorothiazide Film Coated Tablets in Healthy Adult Participants Under Fasted Conditions
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites Viatris and Neolpharma by mouth
The study is seeking for
Both male and female participants
participants who must be 18 to 75 years of age
Body Mass Index of participants should be 16 to 32 kilogram per meter squared and body weight should be more than 50 kilograms 110 pounds
About 40 participants will enter the study 20 in each group Study consists of two periods On Day 1 of each period participants will receive a single amount of Spironolactone and Hydrochlorothiazide tablets The total duration of study will be 71 days Follow up may occur via telephone after 35 days after taking the final tablet of the study medicine
The study is seeking for
Both male and female participants
participants who must be 18 to 75 years of age
Body Mass Index of participants should be 16 to 32 kilogram per meter squared and body weight should be more than 50 kilograms 110 pounds
About 40 participants will enter the study 20 in each group Study consists of two periods On Day 1 of each period participants will receive a single amount of Spironolactone and Hydrochlorothiazide tablets The total duration of study will be 71 days Follow up may occur via telephone after 35 days after taking the final tablet of the study medicine
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None