Bio-availability trial of WosulinÂ® 30/70

A Pilot Study To Compare Bioavailability Between Biphasic Isophane Insulin Injections Wockhardtâ??s WosulinÂ® 30/70 And Actraphane 30, In Healthy Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020383

Enrollment

Registered

2019-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: WosulinÂ® 30/70: WosulinÂ® 30/70, vials 10.0 ml/cartridges 3.0 ml 0.4 IU/kg body weight of study drug will be administered subcutaneously. Control Intervention1: Actraphane 30: Actrapha

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects 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. 2. Subjects with normal health as determined by medical history,clinical examination and laboratory examinations within the clinically acceptable normal range. 3.Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 4. Subjects having clinically acceptable chest X-Ray (PA view).

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Insulin or related class of drugs. 2.Subjects with hemoglobin levels 3.History or presence of significant alcoholism or drug abuse in the past one year. 4. HbA1c values (at screening) >= 5.7%

Design outcomes

Primary

Measure	Time frame
PK:AUC0-24 and Cmax PD:AUCGIR,0-24,and GIRmaxTimepoint: upto 24 hrs of dosing	—

Secondary

Measure	Time frame
PK parameters, PD parameters and Safety assessmentTimepoint: Upto visit 4	—

Countries

India

Contacts

Public ContactDr Mushtaque Mastim

Wockhardt Limited

MMastim@wockhardt.com02226534444

Outcome results