Administration study of long-acting growth hormone preparations in healthy adults

Not Applicable

• Conditions: Healty adult subjectsSample collection for evaluating analysis and sampling methods in antidoping

• Registration Number: JPRN-jRCT1001220001
• Lead Sponsor: Yonemura Takuma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) Men BMI18.5 or more but less than 25.0 at the time of prior examination.
2) Women: BMI 17.6 or more and less than 26.4 at the time of prior examination.
Person who is judged by Principal investigator or Sub-investigator that there is no problem with participation in the test.

Exclusion Criteria

1) Subjects who have had allergic symptoms due to drugs
2) Subjects who are being treated for some disease or who may receive treatment during the study period
3) Those who are suspected of suffering from or have a history of the following diseases
Test drug-1
benign intracranial hypertension, hypoadrenocorticism, diabetes, diabetic complications, brain tumor,
Heart disease, renal dysfunction, liver dysfunction
Test drug-2
malignant tumor, hypothyroidism, hypoadrenocorticism, diabetes, brain tumor, heart disease,
renal dysfunction
4) Subjects who are alcoholic or drug dependent, or have a history of depression.
5) Subjects who used ethical drugs or over-the-counter drugs within 2 weeks of the scheduled administration of the study drug
6)Subjects who took supplements, foods containing St. John's wort, grapefruit, or processed products thereof within 1 week of scheduled administration of the study drug
7) Subjects who received another investigational drug or investigational drug within 16 weeks of the scheduled administration date of the investigational drug, or an investigational drug or investigational drug containing an approved ingredient within 12 weeks
8) Subjects who received 200 mL or more of blood within 30 days of the scheduled administration of the study drug, 400 mL or more of blood within 90 days, and those who received component blood donation within 14 days of the scheduled administration of the study drug.
9) Subjects weighing less than 40kg and 90kg or more at the time of pre-examination
10) Those who are suspected of having a new coronavirus infection
11) Lactating women, pregnant women, and those who may become pregnant during the study period
12) Subjects who are judged inappropriate for participation in this study by the principal investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The evaluation on analysis method by examining the detectable period of the unchanged drug and the metabolite of the test drug

Secondary Outcome Measures

Name	Time	Method
The confirmarion of the influence of the use of the test drug on biological marker variation