Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Idiopathic Short Stature; Healthy; Prader-Willi Syndrome; Genetic Disorder; Growth Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401244

GH-3939

U1111-1121-3640 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
• Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator (trial physician)

Exclusion criteria

• The receipt of any investigational medicinal product within 1 month prior to this trial
• Current or previous treatment with growth hormone or IGF-I (insulin-like growth factor-I)
• Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial
• Known presence or history of malignancy
• Diabetes mellitus
• Use of pharmacologic doses of glucocorticoids
• Use of anabolic steroids
• History of drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Norditropin®

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Genotropin®

Active Comparator group

Treatment:

Drug: somatropin

Drug: somatropin