CTRI/2025/11/097878尚未招募不适用
An open label, balanced, randomized, two-treatment, single-dose, parallel, bioequivalence study of Semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ® (semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
It is an open label, balanced, randomized, two-treatment, single dose, parallel,bioequivalence study of semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ® (semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants under fasting conditions.
The Primary Objective of the study is to demonstrate the bioequivalence between of semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ® (semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants under fasting conditions
The Secondary Objective is To monitor the safety and tolerability of single dose of semaglutide in thestudy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy adult human participants between 18-45 years of age (including both).
- •Participants able to communicate effectively.
- •Voluntary participation.
- •Participants willing to give written informed consent and adhere to all the requirements of this protocol.
- •Body mass index in the range of 18.5 to 29.9 kg/m²
- •Participant who had HbA1c levels lessthan5.7%.
- •Normal 12-lead ECG.
- •Non-smokers and non-alcoholics.
- •Normal chest X-ray (valid for 180 days).
- •Normal values of laboratory parameters.
- •Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL.
- •Participant willing to abstain from all kinds of having caffeine/xanthine containing foods or beverages from 72.00 hours prior to admission until the last blood sample collection in the study.
- •Participants willing to abstain from all kinds of grapefruit/citrus/St john’s wort containing food and juices from at least 07 days prior to admission until the last blood sample collection in study.
- •Participants willing to follow approved birth control methods (a double barrier method) for the duration of the study and for 07 days after last dose as judged by the investigator(s), such as Condom with spermicide, Condom with diaphragm, or abstinence.
- •Female participants: of child bearing potential willing to practice an acceptable method of birth control for the duration of the study and for at least 07 days after last doses such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
- •Or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the participant).
排除标准
- •Volunteers with known a history of contraindication or hypersensitivity (e.g., anaphylaxis) to semaglutide related class of drugs and any of its ingredients.
- •Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study or at least 5 half-lives of the compound whichever period is longer prior to study admission.
- •A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, ophthalmic disorder/disease, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
- •History of diabetic ketoacidosis.
- •Participant with a personal or family history of Medullary Thyroid Carcinoma (MTC) or MEN2 (Multiple Endocrine Neoplasia type 2).
- •History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting).
- •Any history of intolerance to (lactose, fructose, galactose).
- •Participants with secondary causes of obesity for example hypothalamic, monogenic or endocrine Causes Mental health.
- •History of major depressive disorder within 2 years before screening.
- •Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder.
- •A lifetime history of suicidal attempt.
- •History of confirmed diagnosis of bulimia nervosa disorder.
- •History or presence of pancreatitis acute or chronic.
- •History or presence of cholelithiasis
- •History of Type 1 diabetes.
- •Significant illness less than 28 days prior dosing.
- •Participants with a current history of abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
- •History or presence of gastrointestinal (GI) inflammation.
- •History or evidence of exfoliative dermatitis, Stevens.
- •Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
- •Participation in drug study within 90 days prior to dosing.
- •Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug administration.
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •Intolerance to venipuncture.
- •History of addiction to any recreational drug or drug dependence.
- •An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of study period, e.g., fasting due to religious reasons.
- •Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of study period.
- •Positive results for alcohol consumption during the admission of study period.
- •History of pre-existing bleeding disorder.
- •Difficulty with donating blood.
- •Blood pressure on the day of admission of study period Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of study period.
- •History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
- •Females with positive results on serum pregnancy test.
- •Females currently breast-feeding.
- •Female participant who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used oral hormonal contraceptives within 14 days before dosing.
研究者
Dr Venkateshwarlu Yeldandi MD
ADVITY Research Pvt. Ltd.,
研究点 (1)
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