Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants.

In 30 seconds

This randomized controlled trial assessed the safety, pharmacokinetics, and pharmacodynamics of oral bofanglutide in healthy Chinese participants. The study found that single doses of bofanglutide showed a relative bioavailability of 0.56% to 1.31%, with gastrointestinal adverse events being the most common. A 60-minute post-dose fast resulted in approximately twice the exposure compared to a 30-minute fast.

Key findings

• Single-dose relative bioavailability was 0.56% for 30/60 mg and 1.31% for 90 mg.
• Maximum plasma concentration increased from 40.95 to 254.47 ng/mL with dose escalation.
• A 60-minute post-dose fast resulted in 9.22% relative bioavailability compared to 4.88% for a 30-minute fast.

Why it matters

Understanding the pharmacokinetics and safety profile of new medications like bofanglutide is crucial for clinicians managing patients with type 2 diabetes and obesity, as it informs potential treatment options and patient management strategies.