PK-PD trial BETWEEN TWO INSULINS; WOSULIN R (200 IU) WITH WOSULIN R (100 IU) IN HEALTHY SUBJECTS

A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST BIOEQUIVALENCE BETWEEN TWO FORMULATIONS OF RECOMBINANT HUMAN INSULINS; WOSULIN R (200 IU) WITH WOSULIN R (100 IU) IN HEALTHY SUBJECTS. - W-WOS(R)-103

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/07/007117

Enrollment

Registered

2016-07-25

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: Wosulin R (200 IU): Wosulin R (200 IU), 10.0 ml vials or 3ml cartridge with reusable pen. Control Intervention1: Wosulin R (100 IU): Wosulin R (100 IU), 10.0 ml vials or 3ml cartridge

Eligibility

Inclusion criteria

Inclusion criteria: 1.Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, (both inclusive) 2.Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening. 3. Considered generally healthy upon completion of medical history, physical examination, X-ray chest (PA view), ECG, and biochemical investigations.

Exclusion criteria

Exclusion criteria: 1. HbA1c values (at screening) more than 5.7%.

Design outcomes

Primary

Measure	Time frame
PK: AUC0-12 and Cmax PD: AUC (GIR, 0-12h), and GIRmaxTimepoint: PK: 12 hours PD: 12 hours	—

Secondary

Measure	Time frame
PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h, AUC0- ï?¥, tmax, tÂ½ and elimination rate constant (ï?¬z) PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR6-12h, and tGIRmaxTimepoint: Variable	—

Countries

India

Contacts

Public ContactDr Mushtaque Mastim

Wockhardt Ltd

SridharY@wockhardt.com022-26596832

Outcome results