Volunteer Selection:
The volunteers should be free of any condition that can affect the absorption, distribution and elimination of the drug under investigation. This should be assessed from the volunteer history, laboratory tests, and physical examination.
It is recommended that 24 volunteers should be used in the study. They should take the drug on an empty stomach (after 8 hours of fasting). More volunteers may be needed to assess the bioequivalence for drugs that have high variability in their pharmacokinetic parameters.
The bioequivalence of slow release formulations is usually determined under the fasting and the fed conditions.
Sampling Schedule
The sampling schedule after each drug administration should be designed to include:
- At least three samples before the expected tmax
- Samples for three half-lives after the expected tmax
