CTRI/2025/10/096435尚未招募不适用
An open-label, balanced, randomized, single-dose, four treatment, single period, parallel oral bioavailability study comparing the test product of BioMK7 CWD 1 mg capsule and BioMK7 CWS 1 mg capsule by Morel Bio Science Private Limited with that of reference product of Vita MK7 1 mg capsule by Gnosis lesaffre and Menaquine Gold 1 mg capsule by Viridis Biopharma in healthy, adult human participants under fasting conditions.
Morel Bio Science Private Limited1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年11月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To demonstrate the oral bioavailability in healthy adult human subjects under fasting conditions.
研究概览
简要总结
This study is a Nutraceutical study. The title of study is An open-label, balanced, randomized, single-dose, four treatment, single period, parallel, oral bioavailability study comparing the test products BioMK7 CWD 1 mg capsule and BioMK7 CWS 1 mg capsule by Morel Bio Science Private Limited with that of reference products Vita MK7 1 mg capsule by Gnosis lesaffre and Menquine Gold 1 mg capsule by Viridis Biopharma in healthy, adult human participants under fasting conditions. The primary objective of the study is to demonstrate oral bioavailability of the investigational products and the secondary objective of the study is To monitor the safety and tolerability of the test product in healthy, adult, human participants. A total of 44 healthy, adult, human participants shall be enrolled in the study. The total duration of the study will be at least 11 days. A total of 29 pre-dose and post-dose blood samples will be collected in single period for the study to meet primary objective.
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
- All
入选标准
- •Healthy, non-smoking, non-alcoholic, adult, human volunteer (Male and/or non-pregnant, non-lactating female) aged between 18 to 45 years (inclusive of both).
- •Volunteer with a BMI between 18.5 kg/m2 and 30.0 kg/m2 (inclusive of both) and weight at least 50 kgs for male subjects and 45 kgs for female volunteers.
- •Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the dosing.
- •Participant having normal 12-lead electrocardiogram (ECG).
- •Participant having normal chest X- Ray (P/A view).
- •A negative urine screen result for drugs of abuse.
- •Participant able to communicate effectively.
- •Participant willing to adhere to protocol requirements as evidenced by written informed consent approved by an IEC/IRB.
- •Participants willing to give written informed consent and adhere to all the requirements of this protocol.
- •Ability to fast for at least 10.00 hours prior to dosing, 04.00 hours post-dose.
- •Male participant agreeing to use appropriate contraceptive measures like double barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam) and should not donate sperm during the study and for 07 days following last dose of the study medication.
- •If study participant is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: Or Is postmenopausal for at least 1 year.
- •Or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
排除标准
- •Known hypersensitivity to Menaquinone-7 (MK-7), or any of the excipients in the formulation.
- •History or presence of any medical condition or disease according to the opinion of the physician.
- •Volunteers with metabolic or gastrointestinal diseases, chronic degenerative or inflammatory diseases, anaemia, pregnancy, diabetes mellitus, soy allergy, abuse of drugs/alcohol, use of corticosteroids, oral anticoagulants, salicylates, antibiotics, use of vitamin K supplements and high dietary intake of vitamin K.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Difficulty with donating blood or difficulty in accessibility of veins.
- •Difficulty in swallowing capsules.
- •An unusual or abnormal diet within 48.00 hours prior to study check-in, for whatever reason e.g., because of fasting due to religious reasons.
- •Participants who had planned surgery during the course of the trial.
- •History or current diagnosis of any cancer.
- •History or presence of significant alcoholism or drug abuse.
- •History of smoking.
- •History of gall bladder issues.
- •Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute.
- •Respiratory rate less than 14 breaths per minute or more than 18 breaths per minute.
- •Any significant/abnormal values of laboratory tests.
- •Major illness during 90 days before screening.
- •Use of any prescribed medication or OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study.
- •Use of any medications or dietary supplements of Vitamin K during last two weeks.
- •Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and unwilling to follow throughout the study.
- •Participation in a drug research study within past 90 days.
- •Donation of blood in the past 90 days prior to study check-in.
- •In case of female volunteers, Pregnant or lactating Women.
结局指标
主要结局
To demonstrate the oral bioavailability in healthy adult human subjects under fasting conditions.
时间窗: Baseline Pre-dose blood samples will be collected at Day-2 and Day -1, Day 1 and the post-dose samples will be collected on Days 1,2,3,4,5,6 and 8 at 01.00, 02.00, 03.00, 04.00, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00 and 168.00 hours.
次要结局
- To monitor the safety and tolerability of the test product in healthy, adult, human participants.(Vital signs and well-being will be evaluated at the time of screening, check-in and at -48.00, -24.00, 00.00 before dosing and 02.00, 04.00, 06.00, 09.00, 24.00, 36.00, 48.00, and 60.00 hours after dosing and at the time of check-out.)
研究者
Dr C Amulya
Noah Therapeutics Private Limited
研究点 (1)
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