NCT07042828

To Compare and Evaluate the Oral Bioavailability of Bilastine 20 mg Orally Dispersible Tablet With That of Bilaxten (Bilastine) 20 mg Orally Dispersible Tablet in Healthy, Adult, Human Subjects Under Fasting Conditions

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full Replicate, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, balanced, randomized single-dose, two-treatment, two sequence, four-period, Full Replicate, crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.

Conditions

• Allergic Rhino-Conjunctivitis
• Urticaria

Interventions

Type	Name	Description
DRUG	Bilastine oral dispersible tablets	Bilastine 20 mg oral dispersible tablets
DRUG	Bilaxten oral dispersible tablets	Bilaxten 20 mg oral dispersible tablets

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-06-16
• Completion: 2025-06-19
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: India