Healthy VolunteersBENCT05436886

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

A study testing Neurogabin (Gabapentin) 400 mg capsule and Parketin (Gabapentin) 400 mg capsule in people with Healthy Volunteers and Bioequivalence Study, run by University of Karachi at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Bioequivalence Study
What is being tested?: Neurogabin (Gabapentin) 400 mg capsule and Parketin (Gabapentin) 400 mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 sitePakistan
Study dates: 28 Jun 2013to 10 Sep 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue)
Age range for inclusion will be 18-50 year.
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.

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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.

Who cannot join

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.

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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.
Subjects who is unable to or likely to be non-compliant with protocol requirements or restrictions.
Limited mental capacity to the extent that the subject is unable to provide legal consent and information regarding the side effects or tolerance of the study drug.
Pregnancy or breast feeding, women of child bearing age who are not using a recognized form of contraception for at least last 30 days or using hormonal contraception, are also excluded.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh, 75270

Other trials in Pakistan

About this study

Official title: Bioequivalence Study of Gabapentin 400 mg Capsule

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

Read the 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
Being tested: Neurogabin (Gabapentin) 400 mg capsule, Parketin (Gabapentin) 400 mg capsule
Keywords: Bioequivalence Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurogabin (Gabapentin) 400 mg capsuleDrug
Also called Gabapentin 400 mg
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.
Parketin (Gabapentin) 400 mg capsuleDrug
Also called Gabapentin 400 mg
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.

Study groups in NCT05436886
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Neurogabin (Gabapentin) 400 mg capsule; Drug: Parketin (Gabapentin) 400 mg capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum plasma concentration of Gabapentin
Measured: 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
Measured: 0-36 hours post dose
AUC total (AUC 0-∞)
Area under the plasma concentration-time curve from zero to infinity.
Measured: 0-36 hours post dose

Secondary outcomes (1)

Tmax
Time to reach maximum drug concentration in plasma
Measured: 0-36 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201310 Sep 2013

First posted29 Jun 2022
Study start28 Jun 2013
Primary completion5 Jul 2013
Study completion10 Sep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05436886
Sponsor's protocol ID: CB-014-GAB-2012
Acronym: BE
Status last verified: Sep 2022
First submitted: 24 Jun 2022
Last updated: 7 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of Gabapentin 400 mg Capsule
ClinicalTrials.gov ID: NCT05436886
Acronym / sponsor ID: BE / CB-014-GAB-2012
Conditions: Healthy Volunteers, Bioequivalence Study
Keywords: Bioequivalence Study
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of KarachiUniversity, hospital or other
Collaborators: Merck Pvt. Ltd, Pakistan, Center for Bioequivalence Studies and Clinical Research
Study start: 28 Jun 2013 (actual)
Primary completion: 5 Jul 2013 (actual)
Study completion: 10 Sep 2013 (actual)
First posted: 29 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test Group (Neurogabin-M 400 mg) Capsules	Experimental	Drug: Neurogabin (Gabapentin) 400 mg capsule, Drug: Parketin (Gabapentin) 400 mg capsuleA 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.
Reference Group (Parketin 400 mg) Capsules	Active comparator	Drug: Neurogabin (Gabapentin) 400 mg capsule, Drug: Parketin (Gabapentin) 400 mg capsuleA 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue)
Age range for inclusion will be 18-50 year.
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.

Key exclusion criteria (18 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurogabin (Gabapentin) 400 mg capsuleAlso: Gabapentin 400 mgAll 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	Reference Group (Parketin 400 mg) Capsules, Test Group (Neurogabin-M 400 mg) Capsules
Parketin (Gabapentin) 400 mg capsuleAlso: Gabapentin 400 mgAll 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	Reference Group (Parketin 400 mg) Capsules, Test Group (Neurogabin-M 400 mg) Capsules

Primary outcome

Cmax
Time frame: 0-36 hours post dose
Maximum plasma concentration of Gabapentin
AUC last (AUC 0-t)
Time frame: 0-36 hours post dose
Area under plasma concentration time curve from zero to time of the last measurable concentration
AUC total (AUC 0-∞)
Time frame: 0-36 hours post dose
Area under the plasma concentration-time curve from zero to infinity.

1 secondary outcome

Tmax
Time frame: 0-36 hours post dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Dr. Muhammad R Shah, PhD principal investigator

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

Dr. Naghma Hashmi (Co-PI), PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 0-36 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05436886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.