Open label, balanced, randomized, single dose, two treatment, two sequence, two period, crossover oral bioequivalence study in healthy adult human male subjects under fasting conditions.
- Registration Number
- CTRI/2023/08/056242
- Lead Sponsor
- Adeptio Pharmaceutical Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy adult human male subjects aged between 18 and 65 years (inclusive).
Non smokers
Subjects with a BMI between 18.50 –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.
Subjects with an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g. tetrabenazine).
Incapable of understanding the informed consent information.
History of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
History of mania.
History of suicide-related events and/or suicidal ideation.
History of epilepsy, schizophrenia and stroke.
History of a hypokinetic-rigid-syndrome (Parkinsonism).
History of depression.
History of pheochromocytoma.
History 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 of asthma, urticaria or other allergic reactions.
History of gastric and/or duodenal ulceration.
History of thyroid disease, adrenal dysfunction, organic intracranial lesion.
Poor metabolisers i.e. CYP2D6.
Use of reserpine.
History 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. John’s wort) 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: 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.
Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 12 days after the completion of study.
Male volunteer willing to donate sperms during the study till 30 days after the completion of study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method