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Completed

NCT Number: NCT04805827

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)

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharma Guide

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
  • Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
  • Special diet due to any reason, e.g. vegetarian.
  • Subjects who are not suitable to any of inclusion criteria.

Treatment and study plan

Gabapentin

Drug

1 tablet contains 600 mg Gabapentin

Other names: Neurontin

neurontin

Drug

2 capsule contains 2*300 = 600 mg Gabapentin

Primary outcomes

  1. Peak Plasma Concentration (CMAX) of drug gabapentin

    Time frame: 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

    (CMAX) Maximum plasma concentration

  2. Area under the plasma concentration versus time curve (AUC) of gabapentin

    Time frame: 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

    AUC (Area under the concentration-time curve)

Sponsors and collaborators

Lead sponsor

Pharma Guide CRO

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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