Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:51 PM
Study NCT ID:
NCT05102903
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers
Sponsor:
Boryung Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-05
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:
To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.
Detailed Description:
Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.) will be presented for continuous data, and the number (N) and percentage (%) of subjects for each category will be summarized and presented for categorical data. For pharmacokinetic data, the number of subjects, mean, standard deviation, coefficient of variation (primary endpoint only), median, minimum, and maximum will be presented by treatment group.
\<Demographic information statistical analysis\>
* Descriptive statistical analysis will be performed on basic data including demographic information (gender, age, height, weight, BMI, etc.) of all randomized subjects (Intention-To-Treat).
* Continuous data will be compared and tested between sequence groups by summarizing descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.), and by testing whether the data are normally distributed using the independent t-test or Wilcoxon's rank sum test. For categorical data, the number (N) and percentage (%) of subjects for each category will be summarized and compared between the order groups using a Chi-square test or Fisher's exact test.
\<Pharmacokinetic statistical analysis\>
* The pharmacokinetic assessment will be analyzed in subjects who can complete all scheduled blood sampling for pharmacokinetic assessment after administration of the investigational product according to the protocol and can be assessed for pharmacokinetics, and there are no major protocol violations that may affect the pharmacokinetic analysis.
* The pharmacokinetic assessment will be conducted in accordance with Article 17 of the "Drug Equivalence Test Criteria" and the pharmacokinetic parameters will be calculated using a noncompartmental method using the software 'Phoenix® Winnonlin® Ver.8.3 (or higher) (Certara L.P.)'. When calculating pharmacokinetic parameters, the actual sampling time will be used for the sampling time for each subject, and the linear trapezoidal method will be used for the calculation of AUCt. Pharmacokinetic parameters will be summarized and presented descriptively by subject and treatment group. For statistical analysis for equivalence assessment, analysis of variance will be performed for log-transformed values of AUCt and Cmax at a significance level of 0.05. If the 90% confidence interval of the difference between the control drug and the mean value of the study drug is within log 0.8 to log 1.25, the control drug and the study drug will be assessed as equivalent. Descriptive statistics will be presented by treatment group, and they will be compared between treatment groups if necessary.
* The analysis of variance will test the administration period (period), sequence group (sequence), and treatment group (treatment) as fixed effects, and the difference between individuals as linear mixed effect model considering random effects.
\<Safety statistical analysis\>
* The analysis set for safety assessment includes all subjects who received the investigational product at least once.
* Adverse events will be assessed based on the treatment-emergent adverse events (TEAEs) that occur after the administration of the investigational product in Period 1. For TEAEs that occurred during the washout period, hospital admission date, and prior to administration, it will be determined as a TEAE of the investigational product that was administered previously.
Adverse event names will be standardized by SOC (System Organ Class) and PT (Preferred Term) terms using the MedDRA (version 24.0 or higher) classification system, and the analysis of adverse events will be presented as the number of subjects who experienced adverse events, incidence (%), and number of occurrences based on TEAEs. The severity, seriousness, and causal relationship to the investigational product of adverse events will be summarized by treatment group. If necessary, the Chi-square test, Fisher's exact test or McNemar's test will be conducted to test for inter-group differences.
* The names of concomitant medications will be standardized using the WHO ATC (2021 or later) classification system, and subjects who received concomitant medications during the clinical study will be listed. In case of concomitant medications taken during the washout period, hospital admission date, or before the administration, it shall be determined as the concomitant medication of the investigational product that was administered previously.
* For other observation and test items of the subjects such as clinical laboratory tests, vital signs, electrocardiography (ECG), and physical examinations, descriptive statistical analysis will be performed.
\<Demographic information statistical analysis\>
* Descriptive statistical analysis will be performed on basic data including demographic information (gender, age, height, weight, BMI, etc.) of all randomized subjects (Intention-To-Treat).
* Continuous data will be compared and tested between sequence groups by summarizing descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.), and by testing whether the data are normally distributed using the independent t-test or Wilcoxon's rank sum test. For categorical data, the number (N) and percentage (%) of subjects for each category will be summarized and compared between the order groups using a Chi-square test or Fisher's exact test.
\<Pharmacokinetic statistical analysis\>
* The pharmacokinetic assessment will be analyzed in subjects who can complete all scheduled blood sampling for pharmacokinetic assessment after administration of the investigational product according to the protocol and can be assessed for pharmacokinetics, and there are no major protocol violations that may affect the pharmacokinetic analysis.
* The pharmacokinetic assessment will be conducted in accordance with Article 17 of the "Drug Equivalence Test Criteria" and the pharmacokinetic parameters will be calculated using a noncompartmental method using the software 'Phoenix® Winnonlin® Ver.8.3 (or higher) (Certara L.P.)'. When calculating pharmacokinetic parameters, the actual sampling time will be used for the sampling time for each subject, and the linear trapezoidal method will be used for the calculation of AUCt. Pharmacokinetic parameters will be summarized and presented descriptively by subject and treatment group. For statistical analysis for equivalence assessment, analysis of variance will be performed for log-transformed values of AUCt and Cmax at a significance level of 0.05. If the 90% confidence interval of the difference between the control drug and the mean value of the study drug is within log 0.8 to log 1.25, the control drug and the study drug will be assessed as equivalent. Descriptive statistics will be presented by treatment group, and they will be compared between treatment groups if necessary.
* The analysis of variance will test the administration period (period), sequence group (sequence), and treatment group (treatment) as fixed effects, and the difference between individuals as linear mixed effect model considering random effects.
\<Safety statistical analysis\>
* The analysis set for safety assessment includes all subjects who received the investigational product at least once.
* Adverse events will be assessed based on the treatment-emergent adverse events (TEAEs) that occur after the administration of the investigational product in Period 1. For TEAEs that occurred during the washout period, hospital admission date, and prior to administration, it will be determined as a TEAE of the investigational product that was administered previously.
Adverse event names will be standardized by SOC (System Organ Class) and PT (Preferred Term) terms using the MedDRA (version 24.0 or higher) classification system, and the analysis of adverse events will be presented as the number of subjects who experienced adverse events, incidence (%), and number of occurrences based on TEAEs. The severity, seriousness, and causal relationship to the investigational product of adverse events will be summarized by treatment group. If necessary, the Chi-square test, Fisher's exact test or McNemar's test will be conducted to test for inter-group differences.
* The names of concomitant medications will be standardized using the WHO ATC (2021 or later) classification system, and subjects who received concomitant medications during the clinical study will be listed. In case of concomitant medications taken during the washout period, hospital admission date, or before the administration, it shall be determined as the concomitant medication of the investigational product that was administered previously.
* For other observation and test items of the subjects such as clinical laboratory tests, vital signs, electrocardiography (ECG), and physical examinations, descriptive statistical analysis will be performed.
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?: