Standard Operating Procedure for Administration of Study Drug in Fed State in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/059/2025
Supersedes	SOP/BA-BE/059/2022
Page No.	Page 1 of 11
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a standardized procedure for administering the investigational product (IP) under fed conditions to healthy volunteers in Bioavailability/Bioequivalence (BA/BE) studies as per protocol, regulatory, and GCP requirements.

2. Scope

This SOP applies to all fed studies conducted in the BA/BE clinical facility where the administration of the study drug is scheduled after a high-fat, high-calorie meal, as defined by regulatory guidelines and study protocols.

3. Responsibilities

• Clinical Research Coordinator: Ensures subject compliance with fed state protocol and schedules meal and dosing.
• Ward Nurse: Supervises food intake and assists during dosing.
• Principal Investigator/Sub-Investigator: Approves readiness for dosing and oversees drug administration.

4. Accountability

The Principal Investigator is accountable for ensuring that dosing under fed conditions is compliant with the study protocol and regulatory standards.

5. Procedure

5.1 Standard Meal Composition

1. Prepare a standardized high-fat, high-calorie breakfast containing approximately:
   • ~800-1000 kcal
   • ~50% fat, ~30% carbohydrate, ~20% protein
2. Examples: Eggs, buttered toast, fried potatoes, milkshake.
3. Document actual meal served in Annexure-1: Standard Fed Meal Record.

5.2 Meal Timing and Supervision

1. Subjects must consume the entire meal within 30 minutes under supervision.
2. Record start and end time of the meal in Annexure-2: Meal Intake Monitoring Log.
3. Ensure no food or drink is consumed post-meal other than water (as per protocol).

5.3 Study Drug Administration

1. Dose the subject exactly 30 minutes after completion of the fed meal, unless otherwise specified in the protocol.
2. Verify subject identity and treatment allocation before dosing.
3. Document exact dosing time, formulation, and initials of personnel in Annexure-3: Fed-State Dosing Record.

5.4 Post-Dose Monitoring

1. Observe subjects for any immediate adverse events post-dosing.
2. Maintain subject fasting for the post-dose duration as defined in protocol (e.g., 4 hours).
3. Document any protocol deviations or issues encountered.

5.5 Criteria for Exclusion

1. If a subject does not complete the meal or vomits before dosing, consult the PI for continuation decision.
2. Document such events in deviation log and Annexure-4: Fed-State Dosing Exclusion Log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• IP: Investigational Product
• PI: Principal Investigator

7. Documents

1. Standard Fed Meal Record – Annexure-1
2. Meal Intake Monitoring Log – Annexure-2
3. Fed-State Dosing Record – Annexure-3
4. Fed-State Dosing Exclusion Log – Annexure-4

8. References

• US FDA Guidance on Food-Effect Bioavailability and Fed Studies
• ICH E6(R2) – Good Clinical Practice
• Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Standard Fed Meal Record

Subject ID	Meal Items	Calories	Fat %	Meal Supervisor
VOL-059	Omelette, toast, butter, milkshake	950	52%	Sunita Reddy

Annexure-2: Meal Intake Monitoring Log

Subject ID	Meal Start Time	Meal End Time	Compliance	Remarks
VOL-059	07:00	07:25	Yes	Full meal consumed

Annexure-3: Fed-State Dosing Record

Subject ID	Dosing Time	IP Code	Dosed By	Remarks
VOL-059	07:55	TEST-A	Dr. Arvind Shah	No issues

Annexure-4: Fed-State Dosing Exclusion Log

Subject ID	Reason for Exclusion	Action Taken	Investigator	Date
VOL-059X	Incomplete meal	Excluded from dosing	Dr. Arvind Shah	17/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
14/01/2022	1.0	Initial Release	Protocol implementation	QA Head
17/04/2025	2.0	Fed-state specific annexures added	Compliance with US FDA Fed Study Guidelines	QA Head