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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

NCT07042828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-06-29

No results posted yet for this study

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

DRUG

Bilastine oral dispersible tablets

Bilastine 20 mg oral dispersible tablets

DRUG

Bilaxten oral dispersible tablets

Bilaxten 20 mg oral dispersible tablets

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-06-16
Completion
2025-06-19

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042828 on ClinicalTrials.gov