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)

NCT04805827 | Completed DMC

• 1 other identifier: PHG-AMA/GAB-0221/01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pharma Guide; Gabapentin; Neurontin; Mostafa Kaboah

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Gabapentin

EXPERIMENTAL

1 tablet contains 600 mg Gabapentin

Drug: Gabapentin

Neurontin

ACTIVE COMPARATOR

2 capsule contains 2\*300 = 600 mg Gabapentin

Drug: Neurontin

Interventions

Gabapentin DRUG

1 tablet contains 600 mg Gabapentin

Also known as: Neurontin

Gabapentin

Neurontin DRUG

2 capsule contains 2\*300 = 600 mg Gabapentin

Neurontin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Who have a topic constitution or asthma or known allergy for Gabapentin and/or any other ingredients of the products.
• 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.
• Pulse rate less than 60 pulse/minute or more than 100 pulse/minute.
• 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).
• History of difficulty of donating blood.
• History of difficulty of swallowing.
• 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.
• Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• Participation in a drug research study or donating blood within past 2 months before screening.
• 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).
• History of allergic response to heparin.
• Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• 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).
• Founding Positive in the alcohol test done at the time of check in.
• Founding positive in the Urine drugs of abuse at time of check in.

Sponsors & Collaborators

• Pharma Guide CRO: lead

Study Sites (1)

Pharma Guide

Cairo, Egypt

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 Design

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

Model Details: Randomized single oral dose, open-label, two-way, two-periods, UN-replicated crossover design.

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 18, 2021
• Study Start: February 25, 2021
• Primary Completion: March 7, 2021
• Study Completion: March 7, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 01-04-2021

Locations

EG (1)