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NCT00772265
A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects
Phase 1 trial testing Wosulin N in Diabetes in 56 participants. Completed in 1 April 2011.
1 March 2011
Quick facts
| Lead sponsor | Wockhardt |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | health services research |
| Enrollment | 56 |
| Start date | 1 September 2010 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 April 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Diabetes — all drugs for Diabetes →
Sponsor
Wockhardt — full company profile →
Who can join
Adults 18 to 45, any sex, with Diabetes. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean AUC0-24h and Cmax
Time frame: Visit 2 and 3
Sponsor's own description
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The emergence of biosimilar insulin preparations--a cause for concern?
Owens DR, Landgraf W, Schmidt A, Bretzel RG, et al · · 2012 · cited 45× · PMID 23046400 · DOI 10.1089/dia.2012.0105
Verify or expand the search:
- PubMed search for NCT00772265
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Wockhardt trials
Trials by the same sponsor.
- NCT06806995 — A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Met · Phase 1 · completed
- NCT04979806 — Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) · Phase 3 · completed
- NCT03981887 — Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin · Phase 1 · completed
- NCT03622008 — To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) · Phase 1 · completed
- NCT07247942 — Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion. · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00772265 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wockhardt
- Last refreshed: 26 December 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00772265.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing