Status
Conditions
Treatments
About
This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal