CTRI/2023/05/053234已完成Unknown
An open-label, balanced, single dose, three-treatment, three-period, oral bioavailability study thatcompares test formulations of (+) - Alpha - Dihydrotetrabenazine ({+}-α -DHTBZ) 15 mg powder:Adeptio Pharmaceutical Limited, UK) administered as a single 15 mg dose and also as 7.5 mg twice daily dose against an 80 mg single dose of valbenazine (Test 1= 15 mg powder, Test 2= 7.5 mg powder, Test 3= valbenazine 80 mg capsule) in healthy, adult, human subjects under fasting conditions.
Adeptio Pharmaceutical Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy adult human (Male and/or non-pregnant, non-lactating female) subjects aged between 18 and 65 years (inclusive).
- •Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test performed within 21 days prior to initiation of the study. Female subject must have a negative urine pregnancy test prior to check-in of each period. They must be using an acceptable form of contraception.
- •Non smokers
- •Subjects with a BMI between 18.50 â??30.00 kg/m2 (inclusive) and body mass (weight) not less than 50 kg.
- •Subjects in normal health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests).
- •Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
- •Subjects having a normal or clinically not significant chest X-Ray (P/A view) (if taken during screening).
- •A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine) at check in.
- •A negative alcohol breath test result at check in.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •Subjects who can provide adequate evidence of their identity.
- •Availability of volunteer for the entire study duration.
- •Ability to fast and consume standard meals.
排除标准
- •Subjects with an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g. tetrabenazine).
- •Incapable of understanding the informed consent information.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •History or presence of mania.
- •History or presence of suicide-related events and/or suicidal ideation.
- •History or presence of epilepsy, schizophrenia and stroke.
- •History or presence of a hypokinetic-rigid-syndrome (Parkinsonism).
- •History or presence of depression.
- •History or presence of pheochromocytoma.
- •History or presence of pituitary tumours.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
- •Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.
- •History or presence of alcoholism or drug abuse.
- •History or presence of asthma, urticaria or other allergic reactions.
- •History or presence of gastric and/or duodenal ulceration.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •Poor metabolisers i.e. CYP2D6.
- •Use of reserpine.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Difficulty in swallowing liquid like solution or suspension.
- •Difficulty in swallowing apple juice.
- •Use of any prescribed medication or any herbal medication during the two weeks before the start of the study or OTC medicinal products during the week prior to study initiation.
- •Use of monoamine oxidase inhibitors (MAOIs) and/or reserpine during the two weeks before the start of the study.
- •Use with strong CYP3A4 inhibitors (examples: itraconazole, ketoconazole, clarithromycin) during the two weeks before the start of the study.
- •Use with Strong CYP2D6 Inhibitors (examples: paroxetine, fluoxetine, quinidine) during the two weeks before the start of the study.
- •Use with Strong CYP3A4 Inducers (examples: rifampin, carbamazepine, phenytoin, St. Johnâ??s wort) during the two weeks before the start of the study.
- •Use of valbenazine with Digoxin during the two weeks before the start of the study.
- •Subject chewed tobacco / consumed pan or pan masala, gutkha, masala (containing beetle nut and tobacco), xanthine-containing foods or beverages and grape fruit juice for 48.00 hours prior to initiation of the study.
- •Major illness during the 90 days before screening.
- •Participation in a drug research study within 90 days of screening.
- •Donation of blood within 90 days of screening.
- •Positive screening test result for any one or more of the following: Covid-19, HIV, Hepatitis B, Hepatitis C and VDRL.
- •History or presence of easy bruising or bleeding.
- •Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
- •Pregnant woman and nursing mothers.
- •Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
- •Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get
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