ClinicalTrials.gg
Not yet recruitingNCT06549504Updated Aug 14, 2024

Bioequivalence Study of AG2202

A Phase 1 interventional study of AG2202T and AG2202R in Bioequivalence Study, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Not yet recruiting. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bioequivalence Study
03

In context

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects aged 19 years or older at the time of screening
  • Subjects with a of 18.0-30.0 kg/m2
  • Subjects who do not have 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

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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    AG2202T

    Drug: AG2202T

  • Active comparator
    AG2202R

    Drug: AG2202R

Interventions

  • DrugAG2202T

    AG2202T Single-dose

  • DrugAG2202R

    AG2202R Single-dose

06

What researchers measure

Primary outcomes

  1. AUC

    Area under the plasma concentration

    Time frame: Pharmacokinetic plasma samples collected over 36 hour period

  2. Cmax

    Peak Plasma Concentration

    Time frame: Pharmacokinetic plasma samples collected over 36 hour period

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06549504
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Aug 2024 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Aug 14, 2024

Study contacts

Soyeon Jeong
Contact
soyoun1628@ahn-gook.com
+82-2-3289-4359

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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