Ignite Creation Date:
2024-05-06 @ 1:58 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04176367
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2019-11-06
Brief Title:
An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
AN OPEN LABEL RANDOMIZED SINGLE DOSE 2 WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING NICERGOLINE 10 MG TABLET MANUFACTURED AT PFIZER DALIAN CHINA WITH NICERGOLINE 10 MG TABLET MANUFACTURED AT PFIZER ITALIA SRL ITALY UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE PARTICIPANTS
Status:
COMPLETED
Status Verified Date:
2020-11
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:
This trial is a bioequivalence study to support a generic consistency evaluation program initiated by the China Food and Drug Administration CFDA in 2015 for the evaluation of quality and efficacy of the products manufactured in China Related guidance was issued by Center for Drug Evaluation CDE on 27 Nov 2015 named Use pharmacokinetic PK parameter as endpoint for chemical generics bioequivalence BE study
Nicergoline localized product is manufactured at Pfizer Dalian China while the reference product is manufactured at Pfizer Italia Srl Italy The selected strength of 10 mg tablet is the marketed strength in China and the selected dose of 30 mg 3 x 10 mg tablet is one of the commonly used clinically approved daily doses with good tolerability profile
In each group participants will be randomized to one of the 2 treatment sequences according to a computer generated randomization schedule Each treatment sequence will consist of 2 periods separated by a washout period of at least 7 days between the first day of each period
Nicergoline localized product is manufactured at Pfizer Dalian China while the reference product is manufactured at Pfizer Italia Srl Italy The selected strength of 10 mg tablet is the marketed strength in China and the selected dose of 30 mg 3 x 10 mg tablet is one of the commonly used clinically approved daily doses with good tolerability profile
In each group participants will be randomized to one of the 2 treatment sequences according to a computer generated randomization schedule Each treatment sequence will consist of 2 periods separated by a washout period of at least 7 days between the first day of each period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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