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

Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Mizolastine domestic (made in China); Drug: Mizolastine (imported)

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; 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.	Drug: Mizolastine domestic (made in China); Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8; Drug: Mizolastine (imported); Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8
Experimental: Sequence B; 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.	Drug: Mizolastine domestic (made in China); Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8; Drug: Mizolastine (imported); Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)	The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.	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)
Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)	The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.	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)
Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])	The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.	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)
Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])	The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.	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)
Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	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)
Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	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 Outcome Measures

Outcome Measure	Time Frame
Number of volunteers with adverse events as a measure of safety and tolerability	Up to Day 16

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Healthy; Bioequivalence; Mizolastine; Domestic; Imported
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Mizolastine
• Other Study ID Numbers: CR017872; MIZOALY1001 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China)