Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT05667818
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
Sponsor:
Overseas Pharmaceuticals, Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Single Oral Dose Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets, EQ 5mg Base of Overseas Pharmaceuticals Ltd., China and Norvasc®(Amlodipine Besylate) Tablets, 5mg of Pfizer Laboratories Div. Pfizer Inc., in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
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:
Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study.
Major objective:
Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state.
Secondary objective:
To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.
Major objective:
Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state.
Secondary objective:
To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.
Detailed Description:
A single-center, randomized, open, two-cycle, double-cross, fasting experimental design method was adopted. All subjects must sign an informed consent form before taking part in the trial. Physical examination was conducted from the 14th day to the 1st day after administration, and the subjects the investigatorsre randomly assigned to one of the two sequential groups (T-R group and R-T group) according to the ratio of 1:1. That is, in the first cycle, 8 subjects in group T took one tablet of test preparation (amlodipine besylate controlled-release tablet, specification: 5mg) orally on an empty stomach; Group r: 8 subjects took one tablet of control preparation (amlodipine besylate tablet, Luohuoxi, specification: 5 mg) orally on an empty stomach, and about 240 ml of warm water was taken. Cross administration after 14 days.
On the morning of taking medicine, after the collection of blank blood samples, group T took one tablet of the test preparation (amlodipine besylate controlled-release tablets) orally; In group R, the oral control preparation (amlodipine besylate tablet) was taken with about 240 ml warm water. After 4 hours of administration, the standard meal was taken uniformly. Drinking water (except 240 ml water for medicinal purposes) is prohibited within 1 h before and 1 h after administration, and a unified diet is required during the experiment. The cleaning period was 14 days, and after 14 days, the drugs the investigatorsre administered in a cross way.
PK blood collection and blood sample treatment: 0 h before administration (within 1.0 h before administration) and 1.0 h, 2.0 h、3.0 h、3.5 h、4.0 h、4.5 h、5.0 h、5.5 h、6.0 h、6.5 h、7.0 h、7.5 h、8.0 h、8.5 h、9.0 h、10.0 h、12.0 h、14.0 h、16.0 h、24.0 h、36.0 h、48.0 h、72.0 h、96.0 h、144.0 h、168.0 h, a total of 27 time points to collect upper limb venous blood.
0 h before administration (within 1.0 h before administration) and 6.0± 0.5 h、12.0± 0.5 h、24.0±1.0 h、48.0±1.0 h、72.0±1.0 h、96.0±1.0 h、144.0±1.0 h、168.0±1.0 h after administration. The operating procedure of the second cycle is the same as that of the first cycle. In the second cycle, on the day after the sampling, the subjects need physical examination, vital signs examination, electrocardiogram and laboratory examination.
During the study, the investigators should observe and ask the subjective feelings of the subjects and the possible adverse reactions and events during the experiment. If the subject has AE during the trial, the researcher should try to follow up until the adverse events are relieved, or return to the screening level, or the subject's condition is stable.
On the morning of taking medicine, after the collection of blank blood samples, group T took one tablet of the test preparation (amlodipine besylate controlled-release tablets) orally; In group R, the oral control preparation (amlodipine besylate tablet) was taken with about 240 ml warm water. After 4 hours of administration, the standard meal was taken uniformly. Drinking water (except 240 ml water for medicinal purposes) is prohibited within 1 h before and 1 h after administration, and a unified diet is required during the experiment. The cleaning period was 14 days, and after 14 days, the drugs the investigatorsre administered in a cross way.
PK blood collection and blood sample treatment: 0 h before administration (within 1.0 h before administration) and 1.0 h, 2.0 h、3.0 h、3.5 h、4.0 h、4.5 h、5.0 h、5.5 h、6.0 h、6.5 h、7.0 h、7.5 h、8.0 h、8.5 h、9.0 h、10.0 h、12.0 h、14.0 h、16.0 h、24.0 h、36.0 h、48.0 h、72.0 h、96.0 h、144.0 h、168.0 h, a total of 27 time points to collect upper limb venous blood.
0 h before administration (within 1.0 h before administration) and 6.0± 0.5 h、12.0± 0.5 h、24.0±1.0 h、48.0±1.0 h、72.0±1.0 h、96.0±1.0 h、144.0±1.0 h、168.0±1.0 h after administration. The operating procedure of the second cycle is the same as that of the first cycle. In the second cycle, on the day after the sampling, the subjects need physical examination, vital signs examination, electrocardiogram and laboratory examination.
During the study, the investigators should observe and ask the subjective feelings of the subjects and the possible adverse reactions and events during the experiment. If the subject has AE during the trial, the researcher should try to follow up until the adverse events are relieved, or return to the screening level, or the subject's condition is stable.
Study Oversight
Has Oversight DMC:
False
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?: