BA BE trial of Wosulin(Insulin) Regular (E.Coli)

A Randomized, Single Centre, Double Blind Three Treatment Three Period, Crossover Glucose Clamp Study to Test for Bioequivalence between Recombinant Human Insulins, Wockhardtâ??sWosulin Regular Insuln Human (E. Coli) with Wockhardtâ??s Wosulin Regular Insulin Human (Yeast) and Bioequivalence between Wockhardtâ??s Wosulin Regular Insulin Human (E.Coli) with HumulinÂ® R, in Healthy Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006645

Enrollment

Registered

2016-02-16

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: Wockhardts Wosulin R (E.Coli): Wosulin R (E.Coli, 600 nmol/ml, 100 IU/ml), vials 10.0 ml Control Intervention1: Wockhardts Wosulin R (Yeast): Wosulin R (Yeast, 600 nmol/ml, 100 IU/ml)

Eligibility

Inclusion criteria

Inclusion criteria: Male subjects aged between 18 and 45 years both inclusive Subjects weight within the normal range according to normal values for the Body Mass Index -18.50 to 27.00 kg/m2, inclusive with minimum of 50 kg weight Subjects without any evidence of impaired glucose tolerance in 2 hour OGTT. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).

Exclusion criteria

Exclusion criteria: Hypersensitivity to Insulin or related class of drugs. Subjects with hemoglobin levels 12.15 gm/dl at screening or hemoglobinopathy will not be eligible for the study Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.

Design outcomes

Primary

Measure	Time frame
The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: â?¢ Wockhardtâ??s Regular Insulin Human (Yeast) and Wockhardtâ??s Regular Insulin Human (E.Coli) â?¢ Wockhardtâ??s Regular Insulin Human (E.Coli) and HUMULINÂ® R Timepoint: The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: â?¢ Wockhardtâ??s Regular Insulin Human (Yeast) and Wockhardtâ??s Regular Insulin Human (E.Coli) â?¢ Wockhardtâ??s Regular Insulin Human (E.Coli) and HUMULINÂ® R	—

Measure

Time frame

The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: â?¢ Wockhardtâ??s Regular Insulin Human (Yeast) and Wockhardtâ??s Regular Insulin Human (E.Coli) â?¢ Wockhardtâ??s Regular Insulin Human (E.Coli) and HUMULINÂ® R Timepoint: The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: â?¢ Wockhardtâ??s Regular Insulin Human (Yeast) and Wockhardtâ??s Regular Insulin Human (E.Coli) â?¢ Wockhardtâ??s Regular Insulin Human (E.Coli) and HUMULINÂ® R

—

Secondary

Measure	Time frame
The secondary objectives are to compare the pharmacokinetic and pharmacodynamic profile as well as assessing safety and local tolerability of the three insulin preparations.Timepoint: during the 3 clamp	—

Countries

India

Contacts

Public ContactPreeti Narayan

Wockhardt Limited

stawade@wockhardt.com91-22-26596831

Outcome results