Does the test product of amoxicillin 500mg capsules show similar pharmacokinetic parameters as compared to that of the innovator product of amoxicillin 500mg capsules?

Study setting: a private hospital in Colombo, Sri Lanka.

Method of randomization: Simple randomization

Study design: open label, single dose, under fasted and fed conditions comparing the generic (test) product with the innovator, randomized into four treatment periods, as a cross-over study after a wash out period of 7 days

Interventions Innovator product of amoxicillin 500mg capsules (Amoxil 500mg manufactured by GlaxoSmithkline Ltd) as the comparator product and a locally manufactured amoxicillin 500 mg capsule (Axcil 500mg by AstronPvt Ltd) as the test product

Dose: one test product of 500mg amoxicillin capsule and one innovator amoxicillin 500 mg capsule.

Route: Oral

Duration and frequency: Single dose only

Treatment periods Fasted: A single dose of generic or the test product will be administered after 12 hours of overnight fasting.

Subjects to fast overnight (from 8 p.m. only water is allowed). Subjects need to abstain from water for at least one hour before dose. (from 7.00 a.m) Pre dose blood sample will be collected before 8.00 a.m. A single dose of 500 mg amoxicillin trihydrate capsule, either comparator (innovator) or the test formulation will be administered with 240 ml drinking water by 8.00 a.m. Subjects will abstain from drinking water for another one hour after dosing. However, drinking water will be allowed ad libitum after the first hour samples are collected.

Fed: A single dose of the test product will be administered ½ hour after a high calorie high fat meal.

Subjects to fast overnight (from 8 p.m. only water is allowed). Subjects need to abstain from water for at least one hour before dose. (from 7.00 a.m) At 7.30 a.m. standardized breakfast will be served. Pre dose blood sample will be collected before 8.00 a.m. A single dose of 500 mg amoxicillin trihydrate capsule, either comparator (innovator) or the test formulation will be administered with 240 ml drinking water by 8.00 a.m (half an hour after the breakfast).

Subjects will abstain from drinking water for another one hour after dosing. However, drinking water will be allowed ad libitum after the first hour samples are

In period 2 of the study, subjects will cross over to alternative treatment schedule and the same study procedures will be performed. There will be wash out period of 7 days between each intervention.

1. Healthy volunteer males and females of 18-55 years of age.
2. Weight within the normal range according to accepted normal values for the Body Mass Index between 18-25 kg/m2
3. Stable health screening for medical and medical histories, physical examination, vital signs, ECG, Renal Function Test, Liver Function Test, Blood Glucose, Complete Blood Count and urine pregnancy test for females.
4. Preferably be non-smokers and without a history of alcohol or drug abuse.

1. History of allergic reactions to the selected drug and or its constituents
2. History or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug
3. Regular alcohol consumption (more than 1 time/week) or drug abuse
4. Smokers or ex-smoker less than 30 days
5. Use of any drugs within 14 days prior to administration of the first study drug and willing to take them throughout the study period
6. Use of food supplements taken as capsules or tablets or neutraceuticals, vitamins, minerals, herbal remedies, and/or contraceptives hormonal within 14 days before first study drug administration and willing to taking them throughout the study period
7. History of gastrointestinal disease
8. Already participated in another clinical study within last 30 days
9. Pregnant (positive pregnancy test) or breast feeding
10. Blood donation within last 90 days