Pharma Guide
Cairo, Egypt
NCT Number: NCT04805827
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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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 tablet contains 600 mg Gabapentin
Other names: Neurontin
2 capsule contains 2*300 = 600 mg 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
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)
Pharma Guide CRO
Other
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.
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