HealthyNCT04805827
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)
A study testing Gabapentin and Neurontin in people with Healthy, run by Pharma Guide CRO at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gabapentin and Neurontin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2021to 7 Mar 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
- Being tested
- Gabapentin, Neurontin
- Keywords
- Pharma Guide, Gabapentin, Neurontin, Mostafa Kaboah
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
1 tablet contains 600 mg Gabapentin
NeurontinDrug
2 capsule contains 2*300 = 600 mg Gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | 1 tablet contains 600 mg Gabapentin Receives: Drug: Gabapentin |
| Neurontin | Active comparator | 2 capsule contains 2*300 = 600 mg Gabapentin Receives: Drug: Neurontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (CMAX) of drug gabapentin
(CMAX) Maximum plasma concentration
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start25 Feb 2021
- Primary completion7 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized single oral dose, open-label, two-way, two-periods, UN-replicated crossover design.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Guide CRO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kaboah, Pharma Guide CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805827
- Sponsor's protocol ID
- PHG-AMA/GAB-0221/01
- Status last verified
- Sep 2021
- First submitted
- 13 Mar 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04805827
- Acronym / sponsor ID
- PHG-AMA/GAB-0221/01
- Conditions
- Healthy
- Keywords
- Pharma Guide, Gabapentin, Neurontin, Mostafa Kaboah
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pharma Guide CROUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 18 Mar 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized single oral dose, open-label, two-way, two-periods, UN-replicated crossover design.
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin1 tablet contains 600 mg Gabapentin |
| Neurontin | Active comparator | Drug: Neurontin2 capsule contains 2*300 = 600 mg Gabapentin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| GabapentinAlso: Neurontin1 tablet contains 600 mg Gabapentin | Drug | Gabapentin |
| Neurontin2 capsule contains 2*300 = 600 mg Gabapentin | Drug | Neurontin |
Primary outcome
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
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)
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 17 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and Neurontin in people with Healthy, run by Pharma Guide CRO at 1 site in Egypt.
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 11 inclusion and 19 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 17 Sep 2021. 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 Egypt. 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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2021.