Bioequivalence Study of a Generic Azithromycin Tablet 250 mg

Phase 1

Completed

• Conditions: Healthy subjects; Bioequivalence Azithromycin

• Registration Number: TCTR20211222001
• Lead Sponsor: Duopharma Biotech Berhad

Brief Summary

The 94.12%CIs of Ln-transformed Cmax and AUC0-72 of Azithromycin were within the bioequivalence acceptance limits of 80.00-125.00%

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-05-23
• Study Start: 2021-12-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.