Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions

NCT03050164 | Completed Phase 1

• 1 other identifier: KL031-BE-01
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bioequivalence Study

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter：Cmax

  Peak Plasma Concentration (Cmax)

  before drug delivery through 216 hours after dosing

• Pharmacokinetic parameter：AUC

  Area under the plasma concentration versus time curve (AUC)

  before drug delivery through 216 hours after dosing

Study Arms (2)

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.

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.

Drug: Gefitinib Tablet 250mg of Hunan Kelun; Drug: Iressa® Tablet 250mg of AZN

Interventions

Gefitinib Tablet 250mg of Hunan Kelun DRUG

Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.

Also known as: A031

Gefitinib Tablet 250mg of Hunan Kelun; Iressa® Tablet 250mg of AZN

Iressa® Tablet 250mg of AZN DRUG

Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.

Also known as: Iressa®

Gefitinib Tablet 250mg of Hunan Kelun; Iressa® Tablet 250mg of AZN

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Kelun Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2017
• First Posted: February 10, 2017
• Study Start: September 8, 2016
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share