Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-28 @ 9:21 AM
Study NCT ID:
NCT07017335
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2025-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults
Sponsor:
Pharmbio Korea Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301
Status:
COMPLETED
Status Verified Date:
2025-09
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 is a Phase 1, open-label, randomized, crossover clinical trial designed to evaluate the potential drug-drug interaction (DDI) between R1\_PBK\_M2301 (levodropropizine 60 mg) and R2\_PBK\_M2301 (Pelargonium sidoides ethanol extract 11%) in healthy adult volunteers. The study aims to assess the pharmacokinetics of each investigational drug when administered alone and in combination. Approximately \[insert number\] healthy subjects will participate in two treatment periods with appropriate washout intervals. Safety, tolerability, and pharmacokinetic parameters will be evaluated to support future combination development.
Detailed Description:
This Phase 1 clinical trial is designed to assess potential drug-drug interactions between R1\_PBK\_M2301 (levodropropizine 60 mg) and R2\_PBK\_M2301 (Pelargonium sidoides 11% ethanol extract) in healthy adult volunteers. The study adopts an open-label, randomized, two-period crossover design. Each participant will receive both investigational products in different periods, with a washout interval between treatments.
The primary objective is to compare the pharmacokinetic parameters (e.g., C\_max, AUC) of the individual drugs when administered alone versus in combination. Secondary objectives include evaluating safety and tolerability through clinical assessments, vital signs, ECGs, and laboratory tests.
Approximately 24 healthy adults will be enrolled. Each subject will be screened for eligibility based on predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned to one of two sequence groups. Blood samples will be collected at predetermined time points to analyze plasma concentrations of the study drugs.
The findings of this study are expected to support further clinical development and regulatory planning for the combination use of levodropropizine and Pelargonium sidoides extract.
The primary objective is to compare the pharmacokinetic parameters (e.g., C\_max, AUC) of the individual drugs when administered alone versus in combination. Secondary objectives include evaluating safety and tolerability through clinical assessments, vital signs, ECGs, and laboratory tests.
Approximately 24 healthy adults will be enrolled. Each subject will be screened for eligibility based on predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned to one of two sequence groups. Blood samples will be collected at predetermined time points to analyze plasma concentrations of the study drugs.
The findings of this study are expected to support further clinical development and regulatory planning for the combination use of levodropropizine and Pelargonium sidoides extract.
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?: