# Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

> **NCT01561417** · PHASE1 · COMPLETED · sponsor: **Novo Nordisk A/S** · enrollment: 28 (actual)

## Conditions studied

- Acquired Bleeding Disorder
- Acquired Haemophilia
- Congenital Bleeding Disorder
- Congenital FVII Deficiency
- Glanzmann's Disease
- Haemophilia A With Inhibitors
- Haemophilia B With Inhibitors
- Healthy

## Interventions

- **DRUG:** activated recombinant human factor VII
- **DRUG:** activated recombinant human factor VII

## Key facts

- **NCT ID:** NCT01561417
- **Lead sponsor:** Novo Nordisk A/S
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-04
- **Primary completion:** 2006-09
- **Final completion:** 2006-09
- **Target enrollment:** 28 (ACTUAL)
- **Last updated:** 2017-01-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01561417

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01561417, "Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01561417. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
