A Comparative Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions

NCT05356143 | Completed Phase 1 FDA Drug

• 1 other identifier: 2020-4903 Version: 1.0
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study. This study may be conducted in groups. The same protocol requirements and procedures will be followed for each group.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Comparation of drug products

  To compare the levels of desloratadine (UR-12790) and its related metabolites (UR-2788, UR-12767, UR-12766, UR-12335) after single-dose administration of Drug Product 1 and Drug Product 2 in healthy subjects under fasting conditions

  3 weeks

Secondary Outcomes (3)

• Bioavailability of drug product 1

  1 week

• Intra-subject variability

  1 week

• Number of adverse events

  1 week

Study Arms (3)

Sequence 1

OTHER

Subjects will take comparator and active drug at different study periods Treatment sequence AAB

Drug: Rupatadine

Sequence 2

OTHER

Treatment sequence ABA

Drug: Rupatadine

Sequence 3

OTHER

Treatment sequence BAA

Drug: Rupatadine

Interventions

Rupatadine DRUG

Oral single dose 10 mg tablet

Also known as: Pafinur

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-smoking, male and female subjects, 18 years of age or older.
• BMI ≥19 kg/m2.
• Females may be of childbearing or non-childbearing potential:
• Childbearing potential:
• o Physically capable of becoming pregnant
• Non-childbearing potential:
• Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
• Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
• QTc ≤450 msec \[corrected using Bazett's formula (QTcB)\].
• Willing to use acceptable, effective methods of contraception for the duration of the entire study.
• Able to tolerate venipuncture.
• Be informed of the nature of the study and give written consent prior to any study procedure.

You may not qualify if:

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Known or suspected carcinoma.
• Known history or presence of hypersensitivity or idiosyncratic reaction to rupatadine, desloratadine, or any other drug substances with similar activity.
• Known history or presence of clinically significant angioedema.
• Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
• Any acute illness (e.g. cold, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
• Presence of hepatic or renal dysfunction.
• Presence of hay fever, seasonal allergy, or rhinitis.
• Presence of sinusitis.
• Presence of nasal symptoms (e.g., blocked and/or runny nose).
• History of atopic allergy (e.g., asthma, urticaria, eczematous dermatitis).
• History of drug or alcohol addiction requiring treatment.
• Positive test result for COVID-19 Ag, HIV, Hepatitis B surface Ag, or Hepatitis C Ab.
• Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
• Difficulty fasting or consuming standard meals.

Sponsors & Collaborators

• J. Uriach and Company: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1S 3V6, Canada

Location

Related Links

• Medexus Pharmaceuticals Inc. RupallTM, Rupatadine (as rupatidine fumarate), Tablet 10 mg, Oral Solution 1 mg/mL. Canada: Health Canada; Revised June 2, 2020.
• Merck Sharp \& Dohme Corp. Highlights of Prescribing Information. Clarinex® (desloratadine) Tablets, RediTabs, and Oral Solution for oral use. USA: FDA; Revised 3/2019.

MeSH Terms

Interventions

rupatadine

Study Design

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

Model Details: This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: May 2, 2022
• Study Start: December 2, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 5, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)