Bioequivalence Study of AG2202 | NCT06549504

Studies
Bioequivalence Study of AG2202

NCT06549504

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Status

Not yet recruiting

Last Update Posted

Aug 14, 2024Actual

Enrollment

34Estimated

Phase

Phase 1

Conditions

Bioequivalence Study

Interventions

AG2202T
AG2202R

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2024Estimated

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Aug 8, 2024

First Submission Date that Met QC Criteria

Aug 9, 2024

First Posted Date

Aug 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.

Detailed Description

To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AG2202T	Experimental		Drug: AG2202T
AG2202R	Active Comparator		Drug: AG2202R

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AG2202T	Drug	AG2202T Single-dose	AG2202T
AG2202R

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC	Area under the plasma concentration	Pharmacokinetic plasma samples collected over 36 hour period
Cmax	Peak Plasma Concentration	Pharmacokinetic plasma samples collected over 36 hour period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 19 years or older at the time of screening
Subjects with a BMI of 18.0-30.0 kg/m2
Subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination
Subjects who are deemed eligible based on the screening tests

Exclusion Criteria:

Subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose
Subjects who have taken the investigational drug within 6 months prior to the first dose
Subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided