BA/BE study on Aspart mix 30/70 and NOVOMIX 30

Phase 1

Completed

• Registration Number: CTRI/2019/06/019644
• Lead Sponsor: Wockhardt Bio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Subjectâ??s weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight.

Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.

Subjects having clinically acceptable 12-lead electrocardiogram (ECG).

Subjects having clinically acceptable chest X-Ray (PA view).

Non-smoker, defined as no nicotine consumption for last six months.

7. Have a negative urine screen for drugs of abuse {including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)}.

Have a negative alcohol breath analysis.

Subjects willing to adhere to the protocol requirements and are agreed for verbal and written consent to audio-visual recording of the discussion of consent process and agreed to provide the signed and dated informed consent before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.

Exclusion Criteria

Hypersensitivity to Insulin or related class of drugs.

2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

3. Subjects with hemoglobin levels <12.00 gm/dl at screening or hemoglobinopathy will not be eligible for the study

4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration.

5. History or presence of significant alcoholism or drug abuse in the past one year.

6. HbA1c values (at screening) more than 5.7%

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A] Primary Endpoints: <br/ ><br>PK: AUC0-24 and Cmax <br/ ><br>PD: AUCGIR0-24, and GIR max <br/ ><br> <br/ ><br>Timepoint: schedule time for PK samples from dosing till 24 hours post dose.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints: <br/ ><br>PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, AUC12-24h, AUC0-�, tmax, t½ and elimination rate constant (�z) <br/ ><br>PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,, AUCGIR6-12h, AUCGIR6-24h, AUCGIR12-24h and tGIRmax <br/ ><br>Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability. <br/ ><br>Timepoint: upto 24hrs