New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Abbott Healthcare Pvt. Ltd to revise and resubmit the Phase IV Clinical Trial protocol for Clarithromycin Extended Release Tablets 1000 mg after incorporating specific parameters recommended by the committee.
During the SEC meeting held in September 2025, the firm presented the Clinical Trial Protocol for conducting a Phase IV clinical study of Clarithromycin Extended Release Tablets 1000 mg before the committee for review and approval. The study proposal was discussed in detail, focusing on the design, safety assessment parameters, and trial site distribution.
After detailed deliberation, the committee recommended that the following parameters must be included in the revised Phase IV Clinical Trial protocol presented by the firm:
1. Follow-up period should be of two weeks after the third visit.
2. QT prolongation monitoring should be included in the safety assessment parameters.
3. Kidney Function Test (KFT) and Liver Function Test (LFT) should be clearly defined in the protocol.
4. The clinical trial sites should be geographically distributed, including at least 50% government sites.
5. The exclusion criteria should be updated, ensuring that patients with coronary artery disease are excluded from the study.
Accordingly, the committee advised that the firm to submit the revised Phase IV Clinical Trial protocol to CDSCO incorporating all the above recommendations for further consideration.
Clarithromycin is a macrolide antibiotic used for the treatment of bacterial infections caused by susceptible microorganisms. The extended-release formulation (1000 mg) offers sustained plasma levels to enhance therapeutic efficacy and adherence.
Abbott Healthcare Pvt. Ltd, headquartered in Mumbai, operates as part of Abbott Laboratories, a leading global healthcare company engaged in the research, development, and manufacturing of pharmaceutical products across multiple therapeutic segments.
