CTRI/2023/07/055238已完成1 期
A randomized, double blinded, balanced, two treatment, two period, two sequence, cross over, euglycemic clamp study to compare the pharmacokinetic and pharmacodynamic activity of RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix® 30 (30% insulin aspart and 70% insulin aspart protamine suspension) after single dose subcutaneous injection in healthy human adult male subjects under fasting condition. - NI
Mankind Pharma Limited, India0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
- •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%.
排除标准
- •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.
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