Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546215
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Bioequivalence Study of Digoxin Tablet in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Single-dose 025mg Four-period Fully Replicated Bioequivalence Study of Digoxin Tablet Under Fasted and Fed Conditions in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study followed an open-label randomized single-dose 025mg four-period full-replicate design encompassing both fasted and fed conditions Subjects were randomized into two sequences labeled as group A TRTR and group B RTRT for the four sessions By the use of a random table produced by SAS statistical software the individuals were assigned at random to administer a single-dose 025mg of either the reference or the test formulation of digoxin tablets During the fasted study phase participants were randomly administered digoxin tablets after an overnight fast of a minimum of 10 hours and fasting continued for 4 hours post dose During the fed trial subjects consumed a high-fat breakfast 30 minutes before administering digoxin tablets which consisted of approximately 500 to 600 kcal of fat 150 kcal of protein and 250 kcal of carbohydrates totaling around 800 to 1000 kcal calories The breakfast must be finished within 30 minutes Digoxin tablets were administered to each subject in a single dosage with 240 mL of water Each subject was assigned equitably and at random to one of the two groups A 14-day washout period was implemented between each period In the fasted study blood samples were collected at various time points predose 017 033 05 075 1 125 15 175 2 25 3 35 4 5 6 8 12 24 48 72 96 120 and 144 hours after dosing Similarly in the fed study blood samples were collected at predose and at 025 05 075 1 125 15 175 2 225 25 3 35 4 5 6 8 12 24 48 72 96 120 and 144 hours after dosing Following collection the samples underwent centrifugation at 1700g for 10 minutes at 4 The resulting supernatant was then divided into two aliquots and stored at -80 until further analysis was conducted A validated high-performance liquid chromatography with tandem mass spectrometry HPLC-MSMS method was employed to assess the level of digoxin in plasma samples The PK analysis of the plasma concentration-time curve was performed using a non-compartmental modeling method with Phoenix WinNonlin software version 82
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None