Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 5:51 AM
Study NCT ID:
NCT07127094
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations
Sponsor:
Aya Mohammed Abdel Magid Abdel Hamid
Organization:
Study Overview
Official Title:
Open Label, Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to Assess the Bioequivalence of Imeglimin HCl in Glimcoza 500 mg Film Coated Tablet (Test Product) in Comparison With Twymeeg® 500 mg Tablet (Reference Product) in Healthy Subjects Under Fasting Condition
Status:
COMPLETED
Status Verified Date:
2025-08
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:
BEGliTabATCO
Brief Summary:
An open label, randomized, single-dose, two-sequence, two-period, crossover study to assess the bioequivalence of Imeglimin HCl in Glimcoza 500 mg film coated tablet (Test product) in comparison with Twymeeg® 500 mg tablet (Reference product) in healthy 31 subjects under fasting condition.
Detailed Description:
This was a single-dose, open-label, randomized, two-sequence, two-period crossover bioequivalence study conducted under fasting conditions at Advanced Research Center (ARC), Cairo, Egypt in 2025. The study compared the bioequivalence of Imeglimin HCl in Glimcoza 500 mg film coated tablet (Test product) in comparison with Twymeeg® 500 mg tablet (Reference product), both formulations containing Imeglimin HCl. Study Design Participants were randomized in a 1:1 ratio to receive the test or reference product across two study periods, separated by a one-week washout. Each subject received a single oral dose (equivalent to 500 mg Imeglimin HCl) under fasting conditions. A standardized diet was provided during each period, and fluid intake was controlled pre- and post-dosing to maintain consistency. Blood Sampling Details In each period, 22 blood samples (5 mL each) were collected to characterize the plasma concentration-time profile. A forearm vein cannula was used for samples up to 24 hours; later samples were collected via venipuncture. Samples were centrifuged at 3500 rpm for 5 minutes at 4°C. Plasma was separated and stored at -80°C pending analysis. Pharmacokinetic and Bioanalytical Methods Plasma Imeglimin HCl concentrations were quantified using a validated LC-MS/MS method. The primary PK parameters included Cmax AUC(0-inf), and AUC(0-72), while secondary parameters were Tmax, t½, and kel. PK analysis was conducted using Phoenix WinNonlin (v8.3.4), with calculations based on actual sampling times. Bioequivalence Evaluation Bioequivalence was determined if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of Cmax AUC(0-inf), and AUC(0-72) fell within the 80-125% range. ANOVA was applied to log-transformed data for Cmax and AUC, and Wilcoxon signed-rank test was used for Tmax comparisons. Safety Evaluation Subjects were monitored for adverse events throughout the study. Vital signs were assessed at multiple time points (pre-dose, and 2, 4, 6, 12, and 72 hours post-dose). Complete blood counts were performed at the study's end. Statistical Analysis was performed using R (v4.2.1). The Two One-Sided Tests (TOST) procedure was applied to log-transformed PK parameters to assess bioequivalence.
Study Oversight
Has Oversight DMC:
True
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?: