NCT05436886

Bioequivalence Study of Neurogabin-M (Gabapentin 400 mg) Capsule With Parketin (Gabapentin 400 mg) Capsules

Bioequivalence Study of Gabapentin 400 mg Capsule

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Karachi · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.

Detailed description

This is an Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of test drug Neurogabin-M 400 mg, Capsule with reference drug Parketin 400 mg Capsules in healthy adult subjects, under fasting conditions. The study will be comprised of two Periods, I and II, each consisting of 47 hours, 11 hours before and 36 hours after the drug administration. All subjects will be divided into two groups of 12 subjects in each group. One group will be treated with the test drug (T) and the other one with reference drug (R) in Period I. After the wash-out period of 7 days, the same will receive the alternate treatment (RT) in Period II. Blood samples at 0 hr (before drug administration) ,1.0, 1.5 , 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 14.0, 24.0, 28.0, \& 36.0 hrs will be taken in both periods for quantification of drug in plasma. All subjects will be monitored clinically for health status throughout during the periods of study and vital signs will be measured at time of check in and 1, 2, 4, 6, 8, 11, 24 and 36th hours after drug administration. ECG will be measured at time of screening in the best interest of subject safety and well being.

Conditions

• Healthy Volunteers
• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Neurogabin (Gabapentin) 400 mg capsule	All the subjects will receive a single dose of one capsule of either the Test Drug (Neurogabin 400 mg capsule) or Reference Drug (Parketin 400 mg capsule) in one period. if they receive Test in one period, they will alternatively receive Reference drug in the second period.
DRUG	Parketin (Gabapentin) 400 mg capsule	All the subjects will receive a single dose of one capsule of either the Test Drug (Neurogabin 400 mg capsule) or Reference Drug (Parketin 400 mg capsule) in one period. if they receive Test in one period, they will alternatively receive Reference drug in the second period.

Timeline

• Start date: 2013-06-28
• Primary completion: 2013-07-05
• Completion: 2013-09-10
• First posted: 2022-06-29
• Last updated: 2022-09-07

Locations

1 site across 1 country: Pakistan