study to understand bio availability wockhardtâ??s wosulinÂ® 30/70 and actraphane 30 , in healthy subjects

A randomized, single center, double blind, two treatment, Two-period, crossover glucose clamp study to test for Bioequivalence between biphasic isophane insulin injections Wockhardtâ??s wosulinÂ® 30/70 and actraphane 30 , in healthy Subjects - W-WOS(M)-106

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024787

Enrollment

Registered

2020-04-22

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. Single IV dose Control Intervention1: Actraphane 30: Actraphane 30, vials 10.0 ml/cartridges 3.0 ml. Single IV dose

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects weight within the normal range according to normal values for the Body Mass Index with minimum of 50 kg weight. 3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. 4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 5. Subjects having clinically acceptable chest X-Ray (PA view).

Exclusion criteria

Exclusion criteria: 1.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. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration. 4. History or presence of significant alcoholism or drug abuse in the past one year.

Design outcomes

Primary

Measure	Time frame
The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-24h) of two Biphasic Isophane Insulin Injections, WosulinÂ® 30/70 and Actraphane 30 in healthy adult male subjects.Timepoint: 0-24hr	—

Secondary

Measure	Time frame
The secondary objectives are to compare the pharmacokinetic and pharmacodynamic profile as well as assess safety and local tolerability of the two Biphasic Isophane Insulin Injections.Timepoint: 0-24hrs	—

Countries

India

Contacts

Public ContactDr Mushtaque Mastim

wockhardt ltd

MMastim@wockhardt.com02226534444

Outcome results