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Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01400789
Recruitment Status : Withdrawn (Study was not initiated)
First Posted : July 22, 2011
Last Update Posted : January 25, 2013
Sponsor:
Information provided by:
Wockhardt

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE July 22, 2011
Last Update Posted Date January 25, 2013
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01400789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • 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-∞)
  • 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)
  • Safety endpoints [ Time Frame: Over 22 hrs post dose ]
    Number of AE's, SAE's, Hypoglycemic events and local tolerability
  • Pharmacokinetic parameters:Maximum concentration (Cmax) [ Time Frame: Over 22 hrs postdose ]
  • Pharmacokinetic Parameters: tmax and t1/2 [ Time Frame: Over 22 hrs postdose ]
  • Pharmacodynamic parameter: GIR max and tGIR max [ Time Frame: Over 22 hours postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects
Official Title  ICMJE Not Provided
Brief Summary The aim of this study is to assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
Detailed Description The primary objective of this study is assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Bioequivalence in Healthy Subjects
Intervention  ICMJE Biological: Insulin Lispro
Dosage form- Subcutaneous Injection
Other Name: ListroMix 50/50®,Humalog Mix50/50®
Study Arms  ICMJE
  • Experimental: ListroMix 50/50®
    Insulin Lispro/ insulin Lispro protamine ( ListroMix 50/50®; 100 U/mL), DispoPen 3.0 mL.
    Intervention: Biological: Insulin Lispro
  • Active Comparator: Humalog Mix50/50®
    Insulin Lispro/ insulin Lispro protamine (Humalog Mix50/50® ; 100 U/mL), Humalog Mix 50/50® Kwik PenTM 3.0 mL.
    Intervention: Biological: Insulin Lispro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
32
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or female subjects.
  2. Age ≥18 and ≤50 years.
  3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  4. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
  5. Non-smoker, defined as no nicotine consumption for at least one year.
  6. 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:

  1. Previous participation in this trial or other clinical trials within the last 30 days.
  2. 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).
  3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with an 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 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.
  4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
  5. 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.
  6. 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.
  7. Clinically significant abnormal ECG at screening, as judged by the Investigator.
  8. History of alcohol or drug abuse in the past five years.
  9. Any positive screen for drugs of abuse.
  10. Hepatitis B or C or HIV positive.
  11. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
  12. Use of non-prescription drugs, except routine vitamins or herbal products, within 3 weeks prior to the first dose of the test drug.
  13. Occasional use of acetaminophen is permitted. Acetaminophen is not allowed on the dosing day until 4 hours postdosing.
  14. Use of systemic corticosteroids, monoamine oxidase (MAO) inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormones
  15. Thyroid hormones are not allowed unless stable during the past 3 months.
  16. 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.
  17. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
  18. Blood donation of more than 500 ml within the last 12 weeks.
  19. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  20. Known or suspected allergy to trial product or related products.
  21. 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.
  22. Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01400789
Other Study ID Numbers  ICMJE Listro Mix50/50/PK-PD/FDA/2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.R Jha ,Senior Vice-president - Clinical Research, Wockhardt Limited
Study Sponsor  ICMJE Wockhardt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr Ashima Bhatia, MD Wockhardt
PRS Account Wockhardt
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP