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Norditropin FlexPro pen · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Norditropin® | EXPERIMENTAL | - |
| Genotropin® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Norditropin® FlexPro® pen | DRUG | Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
| Genotropin Pen® | DRUG | Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
Inclusion Criteria: * Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I) * Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive) * Considered generally healthy upon completion of medical history, physical examinat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | Somapacitan |
| Ascendis Pharma A/S | ASND | 1 | PHASE3 | Lonapegsomatropin, Somatropin Pen Injector |
Norditropin FlexPro pen is an investigational drug being developed for growth disorder, a condition in the endocrine therapeutic area. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied in healthy volunteers to assess its properties.
Norditropin FlexPro pen is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate this drug for the treatment of growth disorder.
Norditropin FlexPro pen is in Phase 1 clinical development. It is an investigational drug, meaning it is still being studied and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
Norditropin FlexPro pen has been studied in one completed Phase 1 clinical trial, identified as NCT01943084. This trial investigated the bioequivalence of Norditropin (somatropin) versus Genotropin (somatropin) in healthy adult subjects. The trial enrolled 32 participants in the United States and was active-controlled.
Norditropin FlexPro pen contains somatropin, a form of growth hormone. The clinical trial NCT01943084 compared Norditropin (somatropin) with Genotropin (somatropin) to assess bioequivalence. The drug is being developed for growth disorder, and the trial involved healthy volunteers to evaluate its pharmacokinetic properties.