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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928316
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Mizolastine domestic (made in China) Drug: Mizolastine (imported) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers
Study Start Date : June 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pet Health

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




Primary Outcome Measures :
  1. Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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) ]
    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

  2. Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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) ]
    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

  3. Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [ Time Frame: 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) ]
    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.

  4. Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [ Time Frame: 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) ]
    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.

  5. Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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) ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  6. Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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) ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.


Secondary Outcome Measures :
  1. Number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Up to Day 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928316


Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
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Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.
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Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01928316    
Other Study ID Numbers: CR017872
MIZOALY1001 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Healthy
Bioequivalence
Mizolastine
Domestic
Imported
Additional relevant MeSH terms:
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Mizolastine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs