- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050164
Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions
February 8, 2017 updated by: Hunan Kelun Pharmaceutical Co., Ltd.
Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions in Chinese Healthy Male Subjects
The study design is an Open-Label,Randomized, Single-Dose, 2-way Crossover Bioequivalence Study.
During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of AstraZeneca) under fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An Open-Label,Randomized, Single-Dose, 2-way Crossover Bioequivalence Study.
During each session, the subjects were randomly assigned in a 1:1 ratio to receive a single 250-mg dose of either the test formulation(Hunam Kelun) or the reference formulation(Iressa® Astrazeneca), and vice versa, with a 21-day washout period between administration periods.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects.
- At least 18 years of age .
- Weight at least 50kg and body mass index between 19 and 26 kg/m2.
- Informed consent and voluntary to sign a written informed consent.
- Can communicate with researchers and complete the study in accordance with the provisions of the research.
Exclusion Criteria:
- Abnormal diagnostic findings, and clinical significances determined by researchers (physical examination,vital sign, ECG,X-ray,blood routine examination, urine routine examination,blood biochemical examination and coagulation test).
- Having functional gastrointestinal disease or inadequate secretion of gastric acid or is treated for a acid suppression. Which including gastro upset, dyspepsia, gastritis, gastric ulcer, duodenal ulcer, gastric secrete melanoma, etc.
- Taking drugs that alter the environment of the gastrointestinal,especially alter the gastrointestinal pH,within 30 days before the first dose. Such as Proton pump inhibitors:thiophene, omeprazole, lansoprazole, esomeprazole, etc . and H2 antagonist ranitidine:cimetidine, famotidine, etc .and antacids hydrogen carbonate Sodium, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc .and gastric mucosal protective agent:sucralfate,and so on.
- Not comply with a unified diet or has swallowing difficulties.
- Allergic to any ingredient or excipients of the study drug.
- History of gastrointestinal disorders and severe liver and kidney diseases ,which affect the absorption or metabolism of drugs so far.
- History of ocular surface damaging diseases (such as corneal perforation, ulcers, etc.).
- History of serious blood diseases.
- With skin, cardiovascular, liver, kidney, digestive, neurological, psychiatric, metabolic disorders, or any other disease that can interfere with the results of the trial.
- History of long-term excessive drinking (more than 8 cups a day, 1 cup = 250 mL) of tea, coffee or caffeinated beverages,or 48 hours before the first dose intake of any food or drink containing caffeine (such as coffee, tea, chocolate, etc.).
- Ingested any drinks or foods that are rich in xanthine and grapefruit or affect the drug absorption, distribution, metabolism and excretion.
- A positive result in breath alcohol test or previous alcohol abuse (ie, men drink more than 28 standard units a week [1 standard unit defined as containing 14 grams of alcohol, such as would be found in a standard shot of hard liquor, a 12-ounce bottle of beer, or a 5-ounce glass of wine] Or regular drinking(more than 14 standard units of alcohol per week) within 6 months before the trial.
- Daily intake of more than 3 cigarettes from 3 months before the study to 48 hours before the first dose or intake of tobacco or any type of tobacco product within 48 hours before the first dose.
- Taking drugs that interact with gefitinib (such as CYP3A4 inhibitors: itraconazole, ketoconazole, clotrimazole, Ritonavir, etc .and CYP3A4/5 inducers:rifampicin, carbamazepine, phenobarbital, phenytoin, dexamethasone, etc .and CYP2D6 inhibitors:Fluoxetine, paroxetine , etc .) within 30 days before the first dose. And use of any prescription drugs, non-prescription drugs, Chinese herbal medicine, health products within 14 days before the first dose.
- Volunteer in any other clinical drug study or taking any clinical trial drug within 3 months prior to this study.
- Blood donation or lost more than 450mL blood within 3 months prior to the study,or has a plan to donate blood or blood components within the study period or within 3 months after the end of study.
- Suffering from a serious illness or having undergone major surgical procedures within 1 years before the firs dose.
- Abnormal blood coagulation, or having a known tendency of severe bleeding.
- A positive result in drug test or existing drug abuse (eg, morphine, marijuana, methamphetamine, dimethylene bisoxamine amphetamines, ketamine, etc.) within 1 year prior to the trial.
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- Having fertility planning or reluctant to take appropriate contraceptive during the study or within 6 months after the study.
- Other unfavorable factors diagnosed by investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gefitinib Tablet 250mg of Hunan Kelun
During the study session, healthy subjects were orally administered a single dose of Gefitinib Tablet 250mg of Hunan Kelun under fasting conditions.
|
Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.
Other Names:
Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.
Other Names:
|
Active Comparator: Iressa® Tablet 250mg of AZN
During the study session, healthy subjects were orally administered a single dose of Iressa® Tablet 250mg of AZN under fasting conditions.
|
Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.
Other Names:
Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameter:Cmax
Time Frame: before drug delivery through 216 hours after dosing
|
Peak Plasma Concentration (Cmax)
|
before drug delivery through 216 hours after dosing
|
Pharmacokinetic parameter:AUC
Time Frame: before drug delivery through 216 hours after dosing
|
Area under the plasma concentration versus time curve (AUC)
|
before drug delivery through 216 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2016
Primary Completion (Actual)
November 4, 2016
Study Completion (Actual)
November 4, 2016
Study Registration Dates
First Submitted
January 21, 2017
First Submitted That Met QC Criteria
February 8, 2017
First Posted (Actual)
February 10, 2017
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KL031-BE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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