A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mizolastine domestic (made in China); Drug: Mizolastine (imported)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928316

MIZOALY1001 (Other Identifier)

CR017872

Details and patient eligibility

About

The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers

Full description

This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 days.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No history of smoking
• Body mass index between 18 and 28 kilogram per square meter
• Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
• Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study

Exclusion criteria

• Health examination does not comply with the inclusion criteria
• Serious alcohol abuse
• Known allergy to active ingredients or excipients
• Habitual use of any drug including Chinese medicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Sequence A

Experimental group

Description:

Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8.

Treatment:

Drug: Mizolastine domestic (made in China)

Drug: Mizolastine (imported)

Sequence B

Experimental group

Description:

Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8.

Treatment:

Drug: Mizolastine domestic (made in China)

Drug: Mizolastine (imported)