Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70)

A Randomized, Single Center, Double Blind, Two-Period, Crossover Glucose Clamp Study to Test for Bioequivalence between Two Recombinant Human Insulin Analogues - Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) and NovomixÂ® 30, in Healthy Subjects - W-ASP (B)-103

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/050076

Enrollment

Registered

2023-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) 100 IU/ml cartridges 3.0 ml: Dose-0.3 IU/kg subject body weight , Frequency - Single Dose (Once) , Route of administration-Subcut

Eligibility

Inclusion criteria

Inclusion criteria: Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 -kg/m2, 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/tobacco consumption for last six months.

Exclusion criteria

Exclusion criteria: Hypersensitivity to Insulin or related class of drugs. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. Subjects with hemoglobin levels Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. History or presence of alcoholism or drug abuse HbA1c values (at screening) >= 5.7%.

Design outcomes

Primary

Measure	Time frame
To test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-24h) of two Recombinant Human Insulin Analogues - Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) and NovoMixÂ® 30 in healthy adult male subjects.Timepoint: 0-24 hrs	—

Secondary

Measure	Time frame
To compare the pharmacokinetic and pharmacodynamic profile as well as assess safety and local tolerability of the two Recombinant Human Insulin Analogues.Timepoint: Entire duration of study;To test for bioequivalence based on the pharmacodynamic parameters (AUCGIR,0-24h, and GIRmax) of two Recombinant Human Insulin Analogues - Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) and NovoMixÂ® 30 in healthy adult male subjectsTimepoint: 0-24 hrs	—

Measure

Time frame

To compare the pharmacokinetic and pharmacodynamic profile as well as assess safety and local tolerability of the two Recombinant Human Insulin Analogues.Timepoint: Entire duration of study;To test for bioequivalence based on the pharmacodynamic parameters (AUCGIR,0-24h, and GIRmax) of two Recombinant Human Insulin Analogues - Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) and NovoMixÂ® 30 in healthy adult male subjectsTimepoint: 0-24 hrs

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Countries

India

Contacts

Public ContactShraddha Tawade

Wockhardt Limited

Manish.Shah@wockhardt.com02226590000

Outcome results