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NCT01358435 · ClinicalTrials.gov registry record · Phase 1

Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

A Phase 1 study, sponsored by Wockhardt.

Completed
Registry status
Phase 1
Development phase
53
Enrollment target

NCT01358435 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 53 participants.

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The verdict

NCT01358435, a Phase 1 study, has completed, sponsored by Wockhardt.

COMPLETED
Registry status
Phase 1
Development phase
53 participants
Enrollment target

Study Summary

The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.

Interventions

  • BIOLOGICAL 30% Regular Insulin Human Neutral and 70%Isophane Insulin
  • BIOLOGICAL Novolin 70/30

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2011-01
Est. Completion 2011-05
Phase Phase 1

Sponsor

Wockhardt

27 total trials

What the Registry Record Tells You About NCT01358435

The ClinicalTrials.gov registry entry for NCT01358435 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 30% Regular Insulin Human Neutral and 70%Isophane Insulin is the first listed.

NCT01358435 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01358435 about?

NCT01358435 is a clinical study titled "Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects". The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.

What is the current status of trial NCT01358435?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2011-01. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01358435?

The interventions under investigation include: 30% Regular Insulin Human Neutral and 70%Isophane Insulin (BIOLOGICAL), Novolin 70/30 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01358435?

This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.