A comparative pharmacokinetic and pharmacodynamic study of insulin aspart protamine suspension administered as subcutaneous injection in healthy subjects.
- Registration Number
- CTRI/2023/07/055238
- Lead Sponsor
- Mankind Pharma Limited, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. Normal healthy human adult male volunteers aged between 18 -45 years (both
ages inclusive).
2. Volunteer provided written informed consent and are willing to participate in the
study.
3. Volunteer with Body Mass Index of 18.50 to 27.00 Kg/m2
(both inclusive).
4. No evidence of underlying disease during pre-study screening, medical history,
physical examination and laboratory investigations done within 21 days prior to
commencement of the study.
5. Pre-study screening laboratory tests are either normal or within acceptable limits
or are considered by the Investigator to be of no clinical significance with respect
to participation in the study.
6. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
7. Negative test results for alcohol (in urine or in breath), negative urine drugs of
abuse test.
8. Non-smoker, non-tobacco (in any form) users;
9. 12 lead ECG recording either normal or within acceptable limits or considered by
the Investigator to be of no clinical significance with respect to his participation in
the study.
10. Normal or clinically non - significant chest X-ray (PA) taken within 06 months
before the day of dosing.
11. Available for the entire study and capable of understanding instructions and
communicating with the investigators and clinical study facility staff.
12. Who has not undergone vasectomy, must agree to use condoms, or spermicide to
avoid fathering a child during the course of the study and for a period of 07 days
after the last dose administration of investigational product.
13. Volunteer having Oral Glucose Tolerance Test (OGTT) results showing
within normal or within acceptable limits or as considered by the
Investigator to be of no clinical significance with respect to his participation
in the study.
14. Volunteer having HbA1c: less than or equal to 5.6%.
1. Known allergy to Insulin or any component of the formulation and to any other
related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic,
musculoskeletal, neurological or psychiatric disease.
3. History/presence of alcohol abuse or drug abuse.
4. History of smoking, even single cigarette, bidis or any other form.
5. History/presence of asthma.
6. History/presence of urticaria or other allergic type reactions after taking any
medication.
7. History/presence of clinically significant illness within 04 weeks before the start
of the study.
8. History/presence of significant Hypersensitivity to heparin.
9. History of clinically relevant allergy (except for untreated, asymptomatic,
seasonal allergies at time of dosing) or any allergic reactions to any drugs.
10. Scheduled for surgery any time during study or within 07 days after study
completion.
11. History of difficulty in donating blood.
12. With unsuitable veins for repeated venipuncture.
13. Participation in any other clinical or bioequivalence study or otherwise would
have donated in excess of 350 mL of blood in the last 90 days.
14. Consumption of prescription medication or OTC products (including vitamins and
natural products) within 14 days prior to dosing in Period 1, including topical
medication.
15. Hospitalization within 28 days prior to administration of the study medication.
16. History of difficulty in swallowing.
17. Evidence of skin lesions on forearm of signs of vein puncture on the forearm
suggestive of recent donation or participation in clinical trial.
18. With Systolic blood pressure less than 100 mm of Hg or more than 140 mm of
Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the
discretion of the Investigator.
19. With Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion
of the Investigator.
20. Use of any insulin product in the past.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative Bioavalability of test and reference productTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to monitor the safety and tolerability of a single <br/ ><br>dose subcutaneous injection of RapilinTM 30 or NovoMix® 30 when administered in <br/ ><br>healthy human adult male subjects under fasting conditionTimepoint: Vital signs [blood pressure, pulse rate and temperature measurement by infrared <br/ ><br>thermometer] and wellbeing will be assessed after dosing at 01.00, 03.00, 06.00 and <br/ ><br>13.00 hours in each study period. In addition, at all times, subjects may report side effects <br/ ><br>spontaneously to the monitoring staff