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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01401244
• Date of registration: 20/07/2011
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
• Scientific title: A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
• Date of first enrolment: July 14, 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01401244
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Idiopathic Short Stature

Genetic Disorder

Growth Disorder

Healthy

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Area under the serum hGH (human growth hormone) concentration-time curve [Time Frame: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period]

Maximum observed serum hGH concentration [Time Frame: over a 24-hour sampling period]

Secondary Outcome(s)

Abnormal biochemistry laboratory parameters [Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)]

Area under the effect (IGF-I) curve [Time Frame: from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period]

The frequency of injection site reaction [Time Frame: from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively)]

Abnormal findings in physical examinations [Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)]

Abnormal hematology laboratory parameters [Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)]

Vital signs [Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)]

The frequency of adverse events (AE) [Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)]

Maximum IGF-I effect (Emax) [Time Frame: over a 96-hour sampling period]

Secondary ID(s)

GH-3939

U1111-1121-3640

Source(s) of Monetary Support

Please refer to primary and secondary sponsors