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NCT00705536 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20
A Phase 1 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00705536 is a Phase 1 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 26 participants.
The verdict
NCT00705536, a Phase 1 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20). The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.
Interventions
- DRUG Humalog
- DRUG Humulin-R
- DRUG Recombinant human hyaluronidase PH20 (rHuPH20)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00705536
The ClinicalTrials.gov registry entry for NCT00705536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Humalog is the first listed.
NCT00705536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00705536 about?
NCT00705536 is a clinical study titled "Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20". The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidas...
What is the current status of trial NCT00705536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2007-12. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00705536?
The interventions under investigation include: Humalog (DRUG), Humulin-R (DRUG), Recombinant human hyaluronidase PH20 (rHuPH20) (DRUG).
Who is sponsoring clinical trial NCT00705536?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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