Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 8:12 AM
Study NCT ID:
NCT04275492
Status:
TERMINATED
Last Update Posted:
2023-03-31
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
Study Overview
Official Title:
Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor terminated the clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLKS-BE
Brief Summary:
The main purpose of In two kinds of fasting and postprandial Chinese healthy subjects with Boehringer represent Ingelheim company production of hydrochloric acid Pramipexole zyban (specification: 0.26 mg/piece, in Pramipexole, commodity name: Siforl ®) as the reference preparation, study a single oral dose of macro crown biological pharmaceutical co., LTD. Production of Pramipexole Dihydrochloride Sustained Release Tablets (specification:The pharmacokinetic parameters of the drug were calculated after the time course of the drug in vivo (0.375mg/ tablet, as measured by pramipexole hydrochloride), and the human relative bioavailability of the two preparations were compared to evaluate their bioequivalence.
A secondary purpose To evaluate the safety of fasting and postprandial oral test preparations and reference preparations.
A secondary purpose To evaluate the safety of fasting and postprandial oral test preparations and reference preparations.
Detailed Description:
In this study, a single-center, randomized, open, two-cycle, self-crossover, single-dose administration design was used to evaluate the bioequivalence of the tested preparations and reference preparations given to Chinese healthy subjects with single-dose, fasting and post-meal administration of Pramipexole Dihydrochloride Sustained Release Tablets.
This study was divided into two parts: fasting administration and high-fat post-meal administration.The healthy subjects were randomly divided into two groups with the same number of patients in each group. The washing period was 7±1 days.
In this study, venous blood was collected at 18 time points (fasting and postprandial) within 1h (0h) before administration and at 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 9.0h, 10.0h, 11.0h, 12.0h, 16.0h, 36.0h, 48.0h, and 72.0h after administration.
A total of 60 healthy subjects were enrolled into the equivalence test, among which:
1. Study on human bioequivalence of drug administration on an empty stomach: 30 healthy subjects (male and female).
2. Human bioequivalence of high-fat post-meal administration: 30 healthy subjects (male and female).
This study was divided into two parts: fasting administration and high-fat post-meal administration.The healthy subjects were randomly divided into two groups with the same number of patients in each group. The washing period was 7±1 days.
In this study, venous blood was collected at 18 time points (fasting and postprandial) within 1h (0h) before administration and at 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 9.0h, 10.0h, 11.0h, 12.0h, 16.0h, 36.0h, 48.0h, and 72.0h after administration.
A total of 60 healthy subjects were enrolled into the equivalence test, among which:
1. Study on human bioequivalence of drug administration on an empty stomach: 30 healthy subjects (male and female).
2. Human bioequivalence of high-fat post-meal administration: 30 healthy subjects (male and female).
Study Oversight
Has Oversight DMC:
False
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?: