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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (CMAX) of drug gabapentin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Gabapentin
1 tablet contains 600 mg Gabapentin
干预措施: Gabapentin (Drug)
Neurontin
2 capsule contains 2*300 = 600 mg Gabapentin
干预措施: Neurontin (Drug)
结局指标
主要结局
Peak Plasma Concentration (CMAX) of drug gabapentin
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Mostafa Kaboah
Clinical department manager
Pharma Guide CRO