Bioequivalence StudyPhase 1NCT03050164
Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions
A Phase 1 study testing Gefitinib Tablet 250mg of Hunan Kelun and Iressa® Tablet 250mg of AZN in people with Bioequivalence Study, run by Hunan Kelun Pharmaceutical Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Gefitinib Tablet 250mg of Hunan Kelun and Iressa® Tablet 250mg of AZN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2016to 4 Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bioequivalence Study
- Being tested
- Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib Tablet 250mg of Hunan KelunDrug
Also called A031
Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.
Iressa® Tablet 250mg of AZNDrug
Also called Iressa®
Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib Tablet 250mg of Hunan Kelun | Experimental | During the study session, healthy subjects were orally administered a single dose of Gefitinib Tablet 250mg of Hunan Kelun under fasting conditions. Receives: Drug: Gefitinib Tablet 250mg of Hunan Kelun; Drug: Iressa® Tablet 250mg of AZN |
| Iressa® Tablet 250mg of AZN | Active comparator | During the study session, healthy subjects were orally administered a single dose of Iressa® Tablet 250mg of AZN under fasting conditions. Receives: Drug: Gefitinib Tablet 250mg of Hunan Kelun; Drug: Iressa® Tablet 250mg of AZN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter：Cmax
Peak Plasma Concentration (Cmax)
Measured: before drug delivery through 216 hours after dosing
Pharmacokinetic parameter：AUC
Area under the plasma concentration versus time curve (AUC)
Measured: before drug delivery through 216 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start8 Sep 2016
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050164
- Sponsor's protocol ID
- KL031-BE-01
- Status last verified
- May 2026
- First submitted
- 21 Jan 2017
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03050164
- Acronym / sponsor ID
- KL031-BE-01
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefitinib Tablet 250mg of Hunan Kelun | Experimental | Drug: Gefitinib Tablet 250mg of Hunan Kelun, Drug: Iressa® Tablet 250mg of AZNDuring the study session, healthy subjects were orally administered a single dose of Gefitinib Tablet 250mg of Hunan Kelun under fasting conditions. |
| Iressa® Tablet 250mg of AZN | Active comparator | Drug: Gefitinib Tablet 250mg of Hunan Kelun, Drug: Iressa® Tablet 250mg of AZNDuring the study session, healthy subjects were orally administered a single dose of Iressa® Tablet 250mg of AZN under fasting conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefitinib Tablet 250mg of Hunan KelunAlso: A031Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast. | Drug | Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN |
| Iressa® Tablet 250mg of AZNAlso: Iressa®Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast. | Drug | Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN |
Primary outcome
Pharmacokinetic parameter：Cmax
Time frame: before drug delivery through 216 hours after dosing
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameter：AUC
Time frame: before drug delivery through 216 hours after dosing
Area under the plasma concentration versus time curve (AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefitinib Tablet 250mg of Hunan Kelun and Iressa® Tablet 250mg of AZN in people with Bioequivalence Study, run by Hunan Kelun Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter：Cmax (time frame: before drug delivery through 216 hours after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.