Bioequivalence in Healthy SubjectsPhase 1NCT01399255
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects
A Phase 1 study testing Insulin lispro in people with Bioequivalence in Healthy Subjects, run by Wockhardt at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence in Healthy Subjects
- What is being tested?
- Insulin lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2012
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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, 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 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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
About this study
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).
Read the detailed description
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.
- Conditions
- Bioequivalence in Healthy Subjects
- Being tested
- Insulin lispro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin lisproBiological
Also called Listro™ and Humalog®
Dosage form- Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Listro™ Arm | Experimental | Insulin Lispro (Listro™); 100 U/mL, DispoPen 3.0 mL. Receives: Biological: Insulin lispro |
| Humalog® Arm | Active comparator | Insulin Lispro (Humalog®; 100 U/mL), Humalog® Kwik Pen™ 3.0 mL. Receives: Biological: Insulin lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)
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.
Measured: 8 hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-8h)
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
Measured: 8 hrs post dose
Secondary outcomes (6)
Pharmacokinetic parameters:Maximum concentration (Cmax)
Measured: over 10 hrs post dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs
AUC (GIR 0-4h), AUC (GIR 4-8h), AUC (GIR 4-10h), AUC (GIR 0-10h)
Measured: over 10 hrs post dose
Safety endpoints
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Measured: over 10 hrs post dose
Pharmacokinetic parameter: Area under curve from 0-10hrs
AUC (INS-LIS 0-4 h), AUC (INS-LIS 4-8 h), AUC (INS-LIS 4-10h), AUC (INS-LIS 0-10 h)
Measured: over 10 hours postdose
Pharmacokinetic Parameters: tmax and t1/2
Measured: Over 10 hours postdose
Pharmacodynamic parameter: GIR max and tGIR max
Measured: over 10 hrs postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: Study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence in Healthy SubjectsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399255
- Sponsor's protocol ID
- Listro/PK-PD/FDA/2011
- Status last verified
- Jan 2013
- First submitted
- 19 Jul 2011
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01399255
- Acronym / sponsor ID
- Listro/PK-PD/FDA/2011
- Conditions
- Bioequivalence in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Jul 2011 (estimated)
- 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 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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listro™ Arm | Experimental | Biological: Insulin lisproInsulin Lispro (Listro™); 100 U/mL, DispoPen 3.0 mL. |
| Humalog® Arm | Active comparator | Biological: Insulin lisproInsulin Lispro (Humalog®; 100 U/mL), Humalog® Kwik Pen™ 3.0 mL. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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, 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 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.
- 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.
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 |
|---|---|---|
| Insulin lisproAlso: Listro™ and Humalog®Dosage form- Subcutaneous Injection | Biological | Humalog® Arm, Listro™ Arm |
Primary outcome
Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)
Time frame: 8 hrs post dose
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
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
6 secondary outcomes
Pharmacokinetic parameters:Maximum concentration (Cmax)
Time frame: over 10 hrs post dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs
Time frame: over 10 hrs post dose
Safety endpoints
Time frame: over 10 hrs post dose
Pharmacokinetic parameter: Area under curve from 0-10hrs
Time frame: over 10 hours postdose
Pharmacokinetic Parameters: tmax and t1/2
Time frame: Over 10 hours postdose
Pharmacodynamic parameter: GIR max and tGIR max
Time frame: over 10 hrs postdose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin lispro in people with Bioequivalence in Healthy Subjects, run by Wockhardt at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h) (time frame: 8 hrs post dose). 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 25 Jan 2013.