- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400802
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects
January 24, 2013 updated by: Wockhardt
The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter (PK)AUC (INS-LIS 0-20h) and the pharmacodynamic parameter (PD)AUC (GIR 0-20h) and also assess the safety and local tolerability of the two insulin preparations.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 91911
- Profil Institute for Clinical Research, Inc.
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-
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 to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects.
- Age ≥18 and ≤50 years.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
Exclusion Criteria:
- Previous participation in this trial or other clinical trials within the last 30 days.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (e.g. intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant or double barrier method including male condoms used plus spermicide , diaphragm with spermicide plus male condom cap with spermicide plus male condom are acceptable options).
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) or elevated blood glucose at screening as measured by YSI (> 5.5 mmol/L / 100 mg/dL) will not be allowed to enter the trial. Subjects with abnormal TSH may be required to have additional testing of thyroid hormones for further clarification. Subjects with abnormal TSH judged by the Investigator as clinically significant will be excluded from the study.
- Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- History of alcohol or drug abuse in the past five years.
- Any positive screen for drugs of abuse.
- Hepatitis B or C or HIV positive.
- Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
- Use of non-prescription drugs, except routine vitamins or herbal products, within 3 weeks prior to the first dose of the test drug.
- Occasional use of acetaminophen is permitted. Acetaminophen is not allowed on the dosing day until 4 hours postdosing.
- Use of systemic corticosteroids, monoamine oxidase (MAO) inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormones
- Thyroid hormones are not allowed unless stable during the past 3 months.
- Any use of non-steroid anti-inflammatory drugs (NSAIDs) except for low-dose Aspirin is not allowed within 7 days prior to dosing and on the dosing day.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- Blood donation of more than 500 ml within the last 12 weeks.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Known or suspected allergy to trial product or related products.
- History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the Investigator.
- Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Listro Mix75/25®
Insulin Lispro/ insulin Lispro protamine (Listro Mix75/25®; 100 U/mL), DispoPen 3.0 mL.
|
Dosage form- Subcutaneous Injection
Other Names:
|
Active Comparator: Humalog Mix75/25®
Insulin Lispro/ insulin Lispro protamine (Humalog® Mix75/25TM; 100 U/mL), Humalog Mix 75/25® Kwik PenTM 3.0 mL.
|
Dosage form- Subcutaneous Injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence based on Pharmacokinetic parameter: AUC (INS-LIS 0-20h)
Time Frame: 20 hrs post dose
|
Glucose clamp will be terminated 22 hours post dose and the primary pharmacokinetic bioequivalance will be calculated based on the Area under the curve (AUC) between 0 - 20 hours postdose of the study medication.
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20 hrs post dose
|
Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-20h)
Time Frame: 20 hrs post dose
|
Glucose clamp will be terminated 22 hours post dose and the primary pharmacodymanic bioequivalance will be calculated based on the Area under the curve (AUC) for the glucose infusion rate (GIR) between 0 - 20 hours postdose of the study medication
|
20 hrs post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameter: Area under curve from 0-22 hrs
Time Frame: Over 22 hrs post dose
|
AUC (INS-LIS 0-6h), AUC (INS-LIS 6-12h), AUC (INS-LIS 0-12h), AUC (INS-LIS 6-20h), AUC (INS-LIS 0-22h), AUC (INS-LIS 0-∞)
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Over 22 hrs post dose
|
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-22hrs
Time Frame: Over 22 hrs post dose
|
AUC (GIR 0-6h), AUC (GIR 0-12h), AUC (GIR 6-12h), AUC (GIR 6-20h), AUC (GIR 0-22h)
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Over 22 hrs post dose
|
Safety endpoints
Time Frame: Over 22 hrs post dose
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Number of AE's, SAE's, Hypoglycemic events and local tolerability
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Over 22 hrs post dose
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Pharmacokinetic parameters:Maximum concentration (Cmax)
Time Frame: Over 22 hrs postdose
|
Over 22 hrs postdose
|
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Pharmacokinetic Parameters: tmax and t1/2
Time Frame: Over 22 hrs postdose
|
Over 22 hrs postdose
|
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Pharmacodynamic parameter: GIR max and tGIR max
Time Frame: Over 22 hrs postdose
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Over 22 hrs postdose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2011
Primary Completion (Anticipated)
May 1, 2012
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
July 20, 2011
First Submitted That Met QC Criteria
July 20, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2013
Last Update Submitted That Met QC Criteria
January 24, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Listro Mix75/25/PK-PD/FDA/2011
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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