Comparative pharmacokinetic study on an antibiotic on healthy human volunteers
Conditions
Interventions
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 (
Sponsors
University of Colombo
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum drug Concentration in plasma [Serial blood sampling at before dosing (0 hr) and 0.5, 0.75, 1.0, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, and 12.0 hours after dosing] T max: Time to reach maximum drug concentration in plasma [Serial blood sampling at before dosing (0 hr) and 0.5, 0.75, 1.0, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, and 12.0 hours after dosing] AUC: Area Under the Concentration/Time Curve [Serial blood sampling at before dosing (0 hr) and 0.5, 0.75, 1.0, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, and 12.0 hours after dosing] | — |
Secondary
| Measure | Time frame |
|---|---|
| None [None] | — |
Countries
Sri Lanka
Contacts
Public ContactProfessor Priyadarshani Galappatthy
Professor of Pharmacology
Outcome results
None listed