Healthy subjects Bioequivalence Azithromycin
Conditions
Interventions
250 mg, Oral solid dosage form,250 mg, Oral solid dosage form
Experimental Drug,Active Comparator Drug
Azithromycin Tablet 250 mg,Zithromax Tablet 250 mg
Sponsors
Duopharma Biotech Berhad
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Human subjects from 18 to 45 years of age (inclusive of both) 2. Subjects within the BMI range from 18 to 30 kg/m2 (inclusive of both) and the body weight is more than 45 kgs 3. Subjects with normal vital signs (blood pressure, pulse rate, respiratory rate and body temperature). 4. Subjects with normal lymph nodes and other parts like head, neck, eyes, ears, nose, throat and skin 5. Subjects with normal functioning of cardiovascular, respiratory, gastrointestinal, nervous system, musculoskeletal, vascular, genitourinary, endocrine/metabolic systems 6. Subjects with normal medical and surgical history as determined by the physician or principal investigator prior to start of the study 7. Subjects having normal 12-lead electrocardiogram (ECG). 8. Subjects having normal chest X-Ray (P/ A view). 9. History of Non-smoking as informed verbally or ex-smokers 10. Subjects able to communicate effectively 11. Subjects willing to provide consent and adhere to the protocol requirements 12. Subjects with normal laboratory values of investigations as mentioned in the table below.
Exclusion criteria
Exclusion criteria: 1. Contraindications or hypersensitivity to Azithromycin 2. History or presence of any disease in the recent past (hepatic, gastrointestinal, metabolism endocrinological, any type of prophiria, neurological etc.) according to the opinion of the physician. 3. History or presence of significant alcoholism or drug abuse in the past one year 4. History or presence of significant asthma, urticaria or other allergic reactions 5. History of difficulty in donating blood or difficulty in accessibility of veins 6. Difficulty in swallowing tablets 7. Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg. Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg. 8. Pulse rate less than 60/minute or more than 1 00/minute 9. Use of any prescribed medication during last two weeks or OTC medicines or medicinal products during the last one week preceding the check-in until completion of the study. 10. Major illness during 3 months before screening 11. Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening 12. Participation in a drug research study within past 3 months 13. Donation of blood in the past 3 months before screening 14. Refusal to abstain from water for at least 01.00 hour prior to dosing and for at least 01.00 hour post dose. 15. Refusal to abstain from food for at least 10.00 hours prior to dosing and for at least 04.00 hours post dose. Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee, tea, carbonated drinks, chocolate) from 48.00 hours prior to check-in until last sample collection. 16. Presence of disease markers hepatitis B & C virus & VDRL 17. HIV positive 18. Found positive in the alcohol breath test and urine drug of abuse at the time of check-in 19. Evidence of an uncooperative attitude 20. Subjects who comes under vulnerable criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic pre-dose, 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, schedule 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post dose. The Area Under the Curve (AUC) & Maximum concentration (CMAX) percentage will be calculated. The passing range is between 80 - 125% | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety pre-dose, 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, schedule 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post dose. To monitor clinical status, adverse events, laboratory investigations and assess relative safety and tolerance of Azithromycin formulations. | — |
Countries
India
Contacts
Public ContactChuei Wei Leong
Duopharma Innovation consultant
Outcome results
None listed