Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 6:17 AM
Study NCT ID:
NCT04938856
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2021-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
Sponsor:
University of Karachi
Organization:
Study Overview
Official Title:
A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
Status:
COMPLETED
Status Verified Date:
2022-09
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:
BE
Brief Summary:
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.
Detailed Description:
The study drugs will be administered with 240 mL ambient Temperature water after at least 10 hours fasting in each periods.
Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as AUC0-inf) and (AUC0-t)/ (AUC0-inf).
Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as AUC0-inf) and (AUC0-t)/ (AUC0-inf).
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?: