Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Gabapentin From Nerpentin 600 mg (Test ) F.C.T (Aman Pharma ,Egypt.) and Gabapentin From Neurontin 300 mg (Referance ) H.G.C. ( Pfizer Egypt)

Randomized Single Oral Dose, Open-label, Two-way, Two-periods, Un-replicated Crossover, Bioequivalence Study to Compare Nerpentin600 mg Film Coated Tablet (Gabapentin 600 mg) Manufactured by EGPI (Egyptian Group for Pharmaceutical Industry) - Egypt for Aman Pharma, Versus Neurontin 300 mg Hard Gelatin Capsule (Gabapentin 300 mg) a Product of Pfizer Egypt, Under License From: Parke-Davis-Germany, a Company of Pfizer INC., USA, on Healthy Subjects Under Fasting Condition.

This study is conducted with the aim to investigate whether any differences concerning the rate and extent of absorption exist between the test and the reference product, Test product was Nerpentine 600 mg Film coated Tablet (Aman Pharma) Reference Product was Neurontin 300 mg Capsule.(Pfizer) The comparative bio availability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Study was open-label, randomized, crossover, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. one tablet from test product 600 mg against two capsules ( 2*300 mg ) reference product.

Study population was 34 subjects , males ,adults between 18-55 years.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Gabapentin; Drug: Neurontin

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pharma Guide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and non-pregnant female.
2. Subjects should be between the ages of 18 and 55 years.
3. Subject's weight should be within the normal range, preferably have a Body Mass Index between 18.5 and 30 kg/m2.
4. Subjects with normal range of vital signs (Blood Pressure, Pulse Rate.
5. Respiratory Rate and Body Temperature).
6. Normal physical examination at screening visit.
7. Ability to communicate adequately with the investigator himself or his representatives.
8. Ability and agreement to comply with the study requirements.
9. Understanding of the study and agreement to give a written informed consent.
10. The ability of the subjects to understand and comply with the study protocol has to be assessed
11. Females should not be pregnant or lactating.

Exclusion Criteria:

1. Who have a topic constitution or asthma or known allergy for Gabapentin and/or any other ingredients of the products.
2. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration. Systolic blood pressure less than 100 or more than 140 mm Hg and Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
3. Pulse rate less than 60 pulse/minute or more than 100 pulse/minute.
4. History or presence of significant smoking (≥10 cigarettes or consumption of tobacco products and refusal to restrain from smoking or consumption of tobacco products for 48 hours before dosing until checkout).
5. History of difficulty of donating blood.
6. History of difficulty of swallowing.
7. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, hematological, hepatic, gastrointestinal, renal, pulmonary, endocraniological, metabolism or psychiatric disease, any type of porphyria.
8. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
9. Participation in a drug research study or donating blood within past 2 months before screening.
10. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks before the initiation of the study (except single doses of analgesics which have no drug interaction with study product).
11. History of allergic response to heparin.
12. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
13. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day, and refusal to abstain from consumption of these products for 48 hours before dosing until checkout).
14. Founding Positive in the alcohol test done at the time of check in.
15. Founding positive in the Urine drugs of abuse at time of check in.
16. Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
17. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
18. Special diet due to any reason, e.g. vegetarian.
19. Subjects who are not suitable to any of inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gabapentin; 1 tablet contains 600 mg Gabapentin	Drug: Gabapentin; 1 tablet contains 600 mg Gabapentin; Other Names: Neurontin
Active Comparator: Neurontin; 2 capsule contains 2*300 = 600 mg Gabapentin	Drug: Neurontin; 2 capsule contains 2*300 = 600 mg Gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (CMAX) of drug gabapentin	(CMAX) Maximum plasma concentration	0.0, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36 and 48 hours post dose
Area under the plasma concentration versus time curve (AUC) of gabapentin	AUC (Area under the concentration-time curve)	0.0, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36 and 48 hours post dose

Collaborators and Investigators

• Sponsor: Pharma Guide CRO

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): March 7, 2021
• Study Completion (Actual): March 7, 2021

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Gabapentin; Pharma Guide; Neurontin; Mostafa Kaboah
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: PHG-AMA/GAB-0221/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 01-04-2021
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No