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

NCT01928316 | Completed Phase 1

• 2 other identifiers: CR017872MIZOALY1001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Keywords

Healthy; Bioequivalence; Mizolastine; Domestic; Imported

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Number of volunteers with adverse events as a measure of safety and tolerability

  Up to Day 16

Study Arms (2)

Sequence A

EXPERIMENTAL

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); Drug: Mizolastine (imported)

Sequence B

EXPERIMENTAL

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); Drug: Mizolastine (imported)

Interventions

Mizolastine domestic (made in China) DRUG

Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8

Sequence A; Sequence B

Mizolastine (imported) DRUG

Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Serious alcohol abuse
• Known allergy to active ingredients or excipients
• Habitual use of any drug including Chinese medicine

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

MeSH Terms

Interventions

mizolastine

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 23, 2013
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 23, 2013

Record last verified: 2013-08