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

NCT05436886 | Completed

• 1 other identifier: CB-014-GAB-2012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers; Bioequivalence Study

Keywords

Bioequivalence Study

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration of Gabapentin

  0-36 hours post dose

• AUC last (AUC 0-t)

  Area under plasma concentration time curve from zero to time of the last measurable concentration

  0-36 hours post dose

• AUC total (AUC 0-∞)

  Area under the plasma concentration-time curve from zero to infinity.

  0-36 hours post dose

Secondary Outcomes (1)

• Tmax

  0-36 hours post dose

Study Arms (2)

Test Group (Neurogabin-M 400 mg) Capsules

EXPERIMENTAL

A single dose consisting of one capsule of Test Drug (Neurogabin 400 mg capsule) will be administered to each of the subjects in both Periods in fasting conditions with 240 mL ambient temperature water.

Drug: Neurogabin (Gabapentin) 400 mg capsule; Drug: Parketin (Gabapentin) 400 mg capsule

Reference Group (Parketin 400 mg) Capsules

ACTIVE COMPARATOR

A single dose consisting of one capsule of Reference Drug (Parketin 400 mg capsule) will be administered to each of the subjects in both Periods under fasting conditions with 240 mL ambient temperature water.

Drug: Neurogabin (Gabapentin) 400 mg capsule; Drug: Parketin (Gabapentin) 400 mg capsule

Interventions

Neurogabin (Gabapentin) 400 mg capsule DRUG

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.

Also known as: Gabapentin 400 mg

Reference Group (Parketin 400 mg) Capsules; Test Group (Neurogabin-M 400 mg) Capsules

Parketin (Gabapentin) 400 mg capsule DRUG

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.

Also known as: Gabapentin 400 mg

Reference Group (Parketin 400 mg) Capsules; Test Group (Neurogabin-M 400 mg) Capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue)
• BMI for all Subjects will be between 18.5-30.0 kg/m2.
• Participant capable of understanding the informed consent.
• Non Smokers, who have not smoked in last 3 months.
• Medical history, physical examination and screening tests must fall in normal range, unless the investigator considers the abnormality to be clinically not significant.
• Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs of abuse, breath alcohol, Hepatitis B, Hepatitis C and HIV.
• Participants (who can read and understand Urdu) should be able to give informed consent, understand and sign the Informed Consent Form.
• Participants should have adequate organ function (i.e., kidney, liver and heart).
• All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical screening procedures and at each study period check-in.

You may not qualify if:

• Any active allergic disease or a history of any significant allergic disease (e.g. Rhinitis, dermatitis, asthma).
• Known hypersensitivity to Investigational drug(s).
• Abnormal results of blood and urine tests conducted at screening unless the investigator considers an abnormality to be clinically irrelevant.
• Presence or history of cardiac (e.g. Myocardial Infarction, arrythmia), renal (e.g. renal insufficiency) , hepatic (e.g. hepatic impairment) , organ insufficiency, bone marrow disease, hematological abnormality (e.g. leukemia, anemia), photosensitivity, neurological disorders) or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination (e.g. dysphagia, dyspepsia).
• History or presence of any musculo skeletal disease (e.g. Tendonitis).
• Subject donated blood (450ml) within 12 weeks minimum preceding the study.
• Alcoholic or with a history of chronic alcohol intake or consumed alcohol or Gutka in last 3 months.
• Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen).
• History of intake of any prescribed medicine (e.g. Captopril, Sumatriptan) during a period of 30 days, prior to drug administration day of study.
• Ingestion of investigational drug within 30 days, prior to investigational drug administration in the study.
• Ingestion of any known hepatic or renal clearance altering agents (e.g. erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 30 days, prior to study initiation. Drug interaction section at 5.10 and Warnings section at 5.11 should be considered.
• Subjects with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study.
• Subjects with known HIV, hepatitis B or C infection or autoimmune diseases.
• History of drug exposure which, in the opinion of Investigator, amounts to drug abuse (e.g. Amphetamine).
• Participation in other drug studies within three months prior to study initiation.

Sponsors & Collaborators

• University of Karachi: lead
• Merck Pvt. Ltd, Pakistan: collaborator
• Center for Bioequivalence Studies and Clinical Research: collaborator

Study Sites (1)

Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Prof. Dr. Muhammad R Shah, PhD

  Center for bio-equivalence, and clinical research, university of karachi

  PRINCIPAL INVESTIGATOR

• Dr. Naghma Hashmi (Co-PI), PhD

  Center for bio-equivalence, and clinical research, university of karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: June 28, 2013
• Primary Completion: July 5, 2013
• Study Completion: September 10, 2013
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)