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Bioequivalence Study of Azilsartan Tablets in Chinese 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: NCT03652792
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Zhaoke (Guangzhou) Pharmaceutical Limited
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Condition or disease Intervention/treatment Phase
Bioequivalence of Two Azilsartan Formulations Drug: Azilsartan (Zhaoke) Drug: Azilsartan (Takeda) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : July 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azilsartan (Zhaoke) Under Fasting
Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fasting condition
Drug: Azilsartan (Zhaoke)
Azilsartan 20mg tablets from Zhaoke
Other Name: Azilsartan

Active Comparator: Azilsartan (Takeda) Under Fasting
Subjects will take a single Azilva 20mg Tablet under fasting condition
Drug: Azilsartan (Takeda)
Azilva 20mg tablets from Takeda
Other Name: Azilva

Experimental: Azilsartan (Zhaoke) Under Fed
Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fed condition
Drug: Azilsartan (Zhaoke)
Azilsartan 20mg tablets from Zhaoke
Other Name: Azilsartan

Active Comparator: Azilsartan (Takeda) Under Fed
Subjects will take a single Azilva 20mg Tablet under fed condition
Drug: Azilsartan (Takeda)
Azilva 20mg tablets from Takeda
Other Name: Azilva




Primary Outcome Measures :
  1. Bioequivalence under Fasting Condition [ Time Frame: 48 hours ]
  2. Bioequivalence under Fed Condition [ Time Frame: 48 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Males or females between 18 and 40 (inclusive) years of age.
  2. Weight ≥ 50kg and the body mass index (BMI) within the range 19~24kg/m2 (inclusive);
  3. Negative urine hCG pregnancy test.
  4. Non-lactating women and willing to use appropriate contraceptive methods such as an intrauterine device (IUD), diaphragm with spermicides or abstinence or have a sterile sexual partner (e.g., vasectomy) during the whole study period. Men willing to use an appropriate method of contraception (such as condom with spermicide or use by partner of oral, implantable or injectable contraceptives, IUD, diaphragm, with spermicides) or abstinence or will have a sterile sexual partner during the whole study period;
  5. Subjects understand the nature, significance, possible benefits, inconveniences and potential risks before participating in this trial, understood the trial process, and are voluntary to sign the informed consent form and to participate in this trial.

Exclusion Criteria:

  1. Subjects who have abnormalities with clinical significance in physical examination, laboratory examinations, 12-lead ECGs, chest X-ray;
  2. Subjects with clinically significant history of orthostatic hypotension, chronic gastrointestinal disease (such as gastric ulcer, gastritis, etc.), renal disease (such as nephritis, pyelonephritis, etc.), or cardiovascular, respiratory, neurological, psychotic, haematological, endocrine or other disorders within the past 6 months before randomization or at the discretion of the investigators;
  3. Subjects with allergic history to Angiotensin Receptor Blockers or other anti-hypertensive drugs or anti-hypertensive biological agents;
  4. Sitting systolic blood pressure (SBP) <80mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <50mmHg or >90mmHg at screening;
  5. With the history of using any drug which will inhibit (chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid and sulphonamide) or induce liver metabolize drug (barbiturate, carbamazepine, aminoglutethimide, grifulvin, ethanol, ammonia methyl propyl, phenytoin, rifampin, glutethimide, dexamethasone, sulfinpyrazone) within 1 month before randomization;
  6. Vegetarian or abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks prior to screening;
  7. History of alcohol abuse in the last 6 months prior to screening defined as an average weekly intake of greater than 14 unit (one unit is equivalent to 360ml of beer or 45ml of spirits with 40% alcohol content or 150 ml of wine); or subjects with positive alcohol breath test;
  8. History of smoking >5 cigarettes a day in the last 6 months prior to screening;
  9. History of drug abuse and taking drugs (such as marijuana, cocaine, opiates, benzodiazepines, amphetamines, barbiturates, tricyclic antidepressant) or subjects with positive urine drug abuse test results;
  10. Consumption of excessive amount of tea, coffee and/or caffeinated beverage (more than 8 cups/day, 200mL/cup) in the last 1 month prior to screening;
  11. Subjects who have participated in clinical trial (as subjects) in the last 3 months prior to screening;
  12. Blood donation of 250 ml or more in the 3 months prior to screening;
  13. Positive result of hepatitis B antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
  14. Consumption of grapefruit juice, xanthine diet, chocolate, coffee or tea, carbonated beverages, or any other caffeinated beverages within 48 hours before randomization;
  15. Strenuous exercise within 48 hours before randomization;
  16. Administered any drugs (prescription medicine, over-the-counter drug, vitamins, supplements and Chinese herbal medicine) within 2 week before randomization; topical treatment is generally allowed or based on investigators' judgement.
  17. Subjects who, in the opinion of the investigators, should not participate in the study.

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): NCT03652792


Locations
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Hong Kong
Phase I Clinical Trial Centre, Chinese University of Hong Kong
Hong Kong, Sha Tin New Territories, Hong Kong, 000000
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Zhaoke (Guangzhou) Pharmaceutical Limited

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03652792    
Other Study ID Numbers: ZK-HK-AZI-201705
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action