Clinical trial NCT01928316: A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers
Official title: Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Bioequivalence
Mizolastine
Domestic
Imported
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
measure: Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
measure: Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
measure: Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
measure: Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
measure: Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Secondary outcomes:
measure: Number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: Up to Day 16
Other outcomes:
Locations:
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: