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

Department	BA-BE Studies
SOP No.	SOP/BA-BE/060/2025
Supersedes	SOP/BA-BE/060/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standardized procedure for administering the study drug under fasting conditions in Bioavailability/Bioequivalence (BA/BE) studies, ensuring accurate pharmacokinetic assessment and regulatory compliance.

2. Scope

This SOP applies to all clinical trials involving fasted state dosing conducted at the BA/BE unit, covering activities related to fasting enforcement, subject compliance, dosing time, water restrictions, and documentation.

3. Responsibilities

• Clinical Research Coordinator (CRC): Coordinates subject instructions, ensures meal and fasting compliance, and oversees documentation.
• Ward Nurse: Monitors fasting period and prepares subjects for drug administration.
• Principal Investigator/Sub-Investigator: Verifies subject readiness and supervises drug administration.

4. Accountability

The Principal Investigator is accountable for ensuring all study participants meet fasting requirements prior to dosing and that the administration is conducted as per protocol.

5. Procedure

5.1 Fasting Confirmation

1. Ensure a minimum 10-hour overnight fasting as per protocol (unless otherwise specified).
2. Verify fasting start and end time in Annexure-1: Fasting Duration Compliance Log.

5.2 Pre-Dose Water Restriction

1. Permit water intake up to 1 hour prior to dosing, as per protocol.
2. Instruct subjects not to consume any food or caloric beverages post fasting start time.

5.3 Pre-Dose Checks

1. Verify subject identity, treatment code, and fitness to receive dose.
2. Reconfirm compliance with fasting conditions and document any deviation.

5.4 Drug Administration

1. Administer the investigational product with specified quantity of water (e.g., 240 mL) within ±2 minutes of the scheduled time.
2. Record exact dosing time, product code, and initials of personnel in Annexure-2: Fasted State Dosing Record.

5.5 Post-Dose Water and Food Restrictions

1. Restrict additional water intake for 1 hour post dosing.
2. Restrict food for at least 4 hours post dosing or as defined in the protocol.
3. Monitor subjects for adverse events and document in relevant logs.

5.6 Handling Non-Compliance

1. If fasting is not maintained, inform PI immediately for decision on subject withdrawal or continuation.
2. Document deviation in Annexure-3: Dosing Deviation Record and protocol deviation log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator

7. Documents

1. Fasting Duration Compliance Log – Annexure-1
2. Fasted State Dosing Record – Annexure-2
3. Dosing Deviation Record – Annexure-3

8. References

• US FDA Guidance for Industry: Food-Effect Bioavailability and Fed/Fasted Studies
• ICH E6(R2) – Good Clinical Practice
• Study-Specific 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: Fasting Duration Compliance Log

Subject ID	Fasting Start	Dosing Time	Total Fasting (hrs)	Compliance
VOL-060	21:00	07:00	10	Yes

Annexure-2: Fasted State Dosing Record

Subject ID	IP Code	Dosing Time	Water Volume (mL)	Dosed By
VOL-060	TEST-B	07:00	240	Dr. Arvind Shah

Annexure-3: Dosing Deviation Record

Subject ID	Deviation	Action Taken	Investigator	Date
VOL-060X	Consumed food at midnight	Excluded from dosing	Dr. Arvind Shah	17/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial version	Protocol compliance	QA Head
17/04/2025	2.0	Expanded sections and annexures added	Operational clarity	QA Head