Comparative Bioavailability Study of Amoxicillin 600mg/5ml Suspension in Healthy Volunteers
- Registration Number
- CTRI/2012/07/002768
- Lead Sponsor
- Pathway Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
i.Subject who are able and ready to provide written informed consent.
ii.Subjects must be healthy human beings within 18-40 (both figures inclusive) years of age.
iii.Subjects should be of ideal body weight in relation to height according to Life Insurance Corporation of Indiaâ?? height-weight chart for non-medical cases.
iv.Subjects must be of normal health as determined by medical history and physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study.
v.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
i.Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
ii.Significant history of hypersensitivity to Amoxicillin and/or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
iii.Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
iv.Subjects with active peptic ulceration or a history of peptic ulceration.
v.Subject with resting hypotension (BP <90 /60) or hypertension (BP greater than 139 /89).
vi.Subject with Pulse rate below 60 / min. and above 99/min.
vii.Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
viii.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
ix.Subjects with a history of known food allergy.
x.Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
xi.Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
xii.Subject who have a History of drug abuse or alcoholism i.e. alcohol consumption greater than 2 units / day or 10 units / week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer).
xiii.Subject who have Smoking History of greater than 10 Cigarettes / day or Tobacco consumption greater than 4 packets / day.
xiv.Subjects who participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).
xv.Subject with clinically significant abnormal lab values / abnormal ECG.
xvi.Subject who has difficulty with donating blood.
xvii.Subject with positive Breath Alcohol Analysis before admission.
xviii.Subject with positive Urine Drug Screen for drugs of abuse before admission.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the comparative bioavailability of single oral dose of 5mL of ARAMOX-600 (containing Amoxicillin 600mg/5ml) Suspension of Pathway Pharma, LLC and single oral dose of 7.5mL of Amoxicillin 400mg/5ml Suspension of Aurobindo Pharma in 12 healthy human adult subjects under fasting conditionTimepoint: Pre dose (00.00 hour) sample will be collected within 1.5 hours prior to drug administration and the post dose samples will be collected at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours respectively.
- Secondary Outcome Measures
Name Time Method To monitor clinical status, adverse events and assess safety and tolerability of Amoxicillin under fasting condition.Timepoint: Pre dose (00.00 hour) sample will be collected within 1.5 hours prior to drug administration and the post dose samples will be collected at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours respectively.