Healthy volunteer. Acromegaly and pituitary gigantism
Conditions
Interventions
Intervention 1: Intervention Group: Subcutaneous injection of 30 mg Octreotide LAR, manufactured by Varian Pharmed (Variotide), is administered to the patient while fasting. The drug is administered o
Sponsors
The Varianphrmed Company
Eligibility
Sex/Gender
All
Age
19 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants aged between 19 and 55 years Participants with an average body weight of 53-98 kg Participants with normal ranges of glucagon, insulin-like growth factor I (IGF-I), and insulin (based on regular laboratory tests) Participants willing to take part in the trial and capable of signing informed consent form
Exclusion criteria
Exclusion criteria: Any serious adverse drug-related events (SAEs) Any known allergies, hypersensitivity, or intolerance to octreotide acetate, or any severe medical condition for which octreotide is contraindicated High blood glucose levels History of cardiovascular disease or hypertension History of endocrine disorders (pituitary, thyroid, ovarian, testicular, or adrenal gland disorders, based on laboratory tests) or endocrine surgery History of metabolic disorders (based on laboratory tests) History of kidney and liver dysfunction (based on regular functional tests) Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of AUC. Timepoint: on the first day, hours zero, minutes 20, minutes 40, hours 1, 1.5, 2, 3, 5, 7 and 24, then in the morning of days 2, 3, 7, 14, 21, 28, 35, 42, 49 and 56. Method of measurement: To measure serum levels of octreotide, the LC mass/mass method is used.;Comparison of Cmax. Timepoint: on the first day, hours zero, minutes 20, minutes 40, hours 1, 1.5, 2, 3, 5, 7 and 24, then in the morning of days 2, 3, 7, 14, 21, 28, 35, 42, 49 and 56. Method of measurement: To measure serum levels of octreotide, the LC mass/mass method is used.;Comparison serum levels of GH. Timepoint: At times 48, 24, 1 hour and zero time before drug injection and on the first day at zero hours, 20 minutes, 40 minutes, hours 1, 1.5, 2, 3, 5, 7, and 24, then in the morning on days 2, 3, 7, 14, 21, 28, 35, 42, 49, and 56. Method of measurement: DiaSorin S.p.A kits are used to measure the serum levels of hormones.;Comparison serum levels of IGF-1. Timepoint: At times 48, 24, 1 hour and zero time before drug injection and on the first day at zero hours, 20 minutes, 40 minutes, hours 1, 1.5, 2, 3, 5, 7, and 24, then in the morning on days 2, 3, 7, 14, 21, 28, 35, 42, 49, and 56. Method of measurement: DiaSorin S.p.A kits are used to measure the serum levels of hormones.;Comparison serum levels of IGFBF-3. Timepoint: At times 48, 24, 1 hour and zero time before drug injection and on the first day at zero hours, 20 minutes, 40 minutes, hours 1, 1.5, 2, 3, 5, 7, and 24, then in the morning on days 2, 3, 7, 14, 21, 28, 35, 42, 49, and 56. Method of measurement: DiaSorin S.p.A kits are used to measure the serum levels of hormones.;Comparison of Tmax. Timepoint: on the first day, hours zero, minutes 20, minutes 40, hours 1, 1.5, 2, 3, 5, 7 and 24, then in the morning of days 2, 3, 7, 14, 21, 28, 35, 42, 49 and 56. Method of measurement: To measure serum levels of octreotide, the LC mass/mass method is used. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Investigating the number and severity of side effects between the two groups. Timepoint: Before and after drug injection until the end of the study on day 56. Method of measurement: Based on abnormal laboratory results and cases reported by volunteers. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Nazari Dehkordi
The Varianphrmed Company
Outcome results
None listed