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 | Completed Phase 1

• 1 other identifier: 25-VIN-0229
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  90% confidence intervals for the geometric least squares mean ratio of (T/R) will be calculated and reported for Cmax

  24 hours

• Area Under the Curve from time zero to time of last measurable concentration (AUC0-t)

  90% confidence intervals for the geometric least squares mean ratio of (T/R) will be calculated and reported for AUC0-t

  24 hours

Secondary Outcomes (2)

• Area Under the Curve from time zero to time infinite (AUC0-∞)

  24 hours

• Time to reach peak plasma concentration (Tmax)

  24 hours

Study Arms (2)

Bilastine oral dispersible tablets

EXPERIMENTAL

Bilastine 20 mg oral dispersible tablets

Drug: Bilastine oral dispersible tablets; Drug: Bilaxten oral dispersible tablets

Bilaxten oral dispersible tablets

ACTIVE COMPARATOR

Bilaxten 20 mg oral dispersible tablets

Drug: Bilastine oral dispersible tablets; Drug: Bilaxten oral dispersible tablets

Interventions

Bilastine oral dispersible tablets DRUG

Bilastine 20 mg oral dispersible tablets

Bilastine oral dispersible tablets; Bilaxten oral dispersible tablets

Bilaxten oral dispersible tablets DRUG

Bilaxten 20 mg oral dispersible tablets

Bilastine oral dispersible tablets; Bilaxten oral dispersible tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged between 18 and 45 years (both inclusive).
• Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 and 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range \[Annexure III (A)\].
• Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
• Subjects having clinically acceptable chest X-Ray (PA view), if taken.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative urine alcohol test / breath alcohol test.
• Non-smoker.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• For male Subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to refrain from donating sperm during the study period
• For Female Subjects:
• Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam
• Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
• Subjects having negative urine pregnancy test at screening and negative serum -hCG pregnancy test on admission day of period 01 (only for female subjects).

You may not qualify if:

• Hypersensitivity to Bilastine or related class of drugs or any of its excipients or heparin.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
• Presence of alcoholism or drug abuse.
• History or presence of asthma, urticaria or other significant allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• History or presence of cancer or basal or squamous cell carcinoma.
• Difficulty with donating blood.
• Difficulty in swallowing solids dosage form like tablets or capsules.
• Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
• Major illness within past 3 months.
• Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
• Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
• Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Veeda Clinical Research Ltd.

Ahmedabad, Gujarat, 380 051, India

Location

MeSH Terms

Conditions

Urticaria

Interventions

bilastine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: April 30, 2025
• Primary Completion: June 16, 2025
• Study Completion: June 19, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

IN (1)