Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects

This study has been withdrawn prior to enrollment.
(Study was not initiated)
Sponsor:
Information provided by:
Wockhardt
ClinicalTrials.gov Identifier:
NCT01399255
First received: July 19, 2011
Last updated: January 24, 2013
Last verified: January 2013

July 19, 2011
January 24, 2013
November 2011
May 2012   (final data collection date for primary outcome measure)
  • Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h) [ Time Frame: 8 hrs post dose ] [ Designated as safety issue: No ]
    Glucose clamp will be terminated 10 hours post dose and the primary pharmacokinetic bioequivalance will be calculated based on the Area under the curve (AUC) between 0 - 8 hours postdose of the study medication.
  • Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-8h) [ Time Frame: 8 hrs post dose ] [ Designated as safety issue: No ]
    Glucose clamp will be terminated 10 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 - 8 hours postdose of the study medication
Same as current
Complete list of historical versions of study NCT01399255 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters:Maximum concentration (Cmax) [ Time Frame: over 10 hrs post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs [ Time Frame: over 10 hrs post dose ] [ Designated as safety issue: No ]
    AUC (GIR 0-4h), AUC (GIR 4-8h), AUC (GIR 4-10h), AUC (GIR 0-10h)
  • Safety endpoints [ Time Frame: over 10 hrs post dose ] [ Designated as safety issue: Yes ]
    Number of AE's, SAE's, Hypoglycemic events and local tolerability
  • Pharmacokinetic parameter: Area under curve from 0-10hrs [ Time Frame: over 10 hours postdose ] [ Designated as safety issue: No ]
    AUC (INS-LIS 0-4 h), AUC (INS-LIS 4-8 h), AUC (INS-LIS 4-10h), AUC (INS-LIS 0-10 h)
  • Pharmacokinetic Parameters: tmax and t1/2 [ Time Frame: Over 10 hours postdose ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameter: GIR max and tGIR max [ Time Frame: over 10 hrs postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects
Not Provided

The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).

The purpose of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects, based on the pharmacokinetic parameter (PK) AUC (INS-LIS 0-8h) and the pharmacodynamic parameter (PD) AUC (GIR 0-8h) and also assess the safety and local tolerability of the two insulin preparations.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Bioequivalence in Healthy Subjects
Biological: Insulin lispro
Dosage form- Subcutaneous Injection
Other Name: Listro™ and Humalog®
  • Experimental: Listro™ Arm
    Insulin Lispro (Listro™); 100 U/mL, DispoPen 3.0 mL.
    Intervention: Biological: Insulin lispro
  • Active Comparator: Humalog® Arm
    Insulin Lispro (Humalog®; 100 U/mL), Humalog® Kwik Pen™ 3.0 mL.
    Intervention: Biological: Insulin lispro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
May 2012   (final data collection date for primary outcome measure)

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, 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 fasting blood glucose, 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 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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01399255
Listro/PK-PD/FDA/2011
No
Dr.R Jha ,Senior Vice-president - Clinical Research, Wockhardt Limited
Wockhardt
Not Provided
Not Provided
Wockhardt
January 2013

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