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

NCT05436886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers
  • Bioequivalence Study

Interventions

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.

Sponsors & Collaborators

  • Merck Pvt. Ltd, Pakistan

    collaborator UNKNOWN

  • Center for Bioequivalence Studies and Clinical Research

    collaborator OTHER

  • University of Karachi

    lead OTHER

Principal Investigators

  • Prof. Dr. Muhammad R Shah, PhD · Center for bio-equivalence, and clinical research, university of karachi

  • Dr. Naghma Hashmi (Co-PI), PhD · Center for bio-equivalence, and clinical research, university of karachi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-28
Primary Completion
2013-07-05
Completion
2013-09-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436886 on ClinicalTrials.gov