CTRI/2024/04/066196尚未招募Unknown
An open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover bioequivalence study of Propiomazine Tablets 25 mg [Test] of Centaur Pharmaceuticals Pvt. Ltd. India with Propavan® 25 mg (Propiomazine Tablets 25 mg) [Reference] of Sanofi-aventis AB, Stockholm, Sweden, in healthy, adult, human Subjects under fasting conditions. - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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
- •1. Healthy, Indian, male and/ or non-pregnant, non-lactating female, human volunteers aged from = 18 to = 45 years.
- •2. Weight not less than 50 Kg. and body mass index should be within 18.50–27.00 kg/m2 [weight in kg / (height in m)2].
- •3. Voluntarily willing and capable to give written and signed informed consent prior to participation in the study.
- •4. Availability for the entire study period and willingness to adhere to the protocol and study requirements.
- •5. Willing to undergo pre- and post-study physical examinations and laboratory investigations.
- •6. Having no current or past significant disease as well as clinically significant observations from medical history or physical examination or vital signs examination during screening.
- •7. Having normal values or clinically insignificant abnormal values of investigations of clinical laboratory examination during screening.
- •8. 12-lead supine ECG in resting position is within normal limits or showing clinically insignificant artifacts as per qualified medical staff.
- •9. Normal chest X-ray findings or findings that have no clinical correlation.
- •10. Having not consumed alcohol at least 24.000 hrs. prior to admission in the study justified by negative urine-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
- •11. Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocannabinoids, morphine, cocaine, benzodiazepine).
- •12. Not consumption of xanthine-containing derivatives [coffee, tea, cola drinks, chocolate] and grapefruit or orange or citrus fruits/ juice/ products for at least 48.000 hrs. prior to admission in the study.
- •13. Non-smokers [Definition – Those who do not have history of smoking or having quit smoking for more than 3 years].
- •14. Non-pregnant female Subject confirmed by negative serum ß-hCG test [defined by value = 5.7 mIU/mL] performed on the admission day.
- •15. Male Subjects of reproductive potential who agree to follow acceptable forms of contraception including – sexual abstinence and barrier methods [e.g. condoms] or those who have undergone vasectomy.
- •16. Female subject of reproductive potential agrees to remain abstinent or use highly effective contraception throughout the study.
- •17.Subjects who are of non-reproductive potential, i.e., Subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea).
排除标准
- •1. H/O allergy or sensitivity to propiomazine or phenothiazines or to any of the excipients of drug product, which, in the opinion of the investigator, would compromise the safety of the Subject.
- •2. History or presence of hepatic dysfunction established by elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase [at least 1.5 times of upper normal range].
- •3. History or presence of renal function impairment established by serum creatinine 1.5 times or more of upper reference range.
- •4. History or presence of any other clinically relevant systemic disease such as renal, hepatic, pulmonary, cardiac, gastrointestinal endocrine or metabolic disorder (e.g. diabetes mellitus, galactose intolerance, glucose-galactose malabsorption, lactose intolerance), malignancy or immunodeficiency disorder.
- •5. Irregular mealtimes, skipping meals, periods of fasting or dietary changes within last 3 months prior to enrollment in the study.
- •6. Participation in another clinical study or a blood donation program or having had blood loss of more than 450 mL during the last 90 days.
- •7. Seropositive for VDRL, HIV or hepatitis B or C infection.
- •8. Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data, X-ray interpretation and full physical examination.
- •9. Vital sign abnormalities.
- •10. Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study.
- •11. Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug.
- •12. Having taken OTC or prescribed medications, including any enzyme-modifying drugs, antidepressants, hypnotics, barbiturates, opioids, other sedatives or any systemic medication [with the exception of contraceptive pills consumed by female volunteers], within the last 07 days prior to the study.
- •13. Having a history of alcohol or substance abuse within the last 5 years.
- •14. Habit of chewing or inhaling nicotine-containing products.
- •15. Abnormal INR combined with clinical manifestation
研究者
相似试验
已完成
1 期
A clinical trial study to determine the bioavailability of different formulations of curcumin tablets.CTRI/2021/06/034356KMS Health Center Pvt Ltd
已完成
不适用
3 PERIOD FASTING STUDY IN HEALTHY, ADULT, MALES, RANDOMLY DOSED IN EACH PERIOD WITH 2000mg OF CURCUMINOIDS FROM LIQUID CURCUMIN or with CURCUMINOID POWDER WITH TURMERIC ESSENTIAL OIL IN VEGETARIAN CAPSULES OR WITH CURCUMINOID POWDER WITH PIPERINE IN VEGETARIAN CAPSULESCTRI/2019/04/018513Halycon Bioscience pty Ltd9
已完成
1 期
A clinical trial study to determine the oral bio-availability of Caffxtend capsules.CTRI/2021/06/034185Inventia Healthcare Limited16
尚未招募
不适用
Clopidogrel Tablets USP 300 mgBE Fasting StudyCTRI/2019/04/018856Polygen Pharmaceuticals Inc
已完成
1 期
Comparative assessment of the absorption of a generic formulation of asenapine sublingual tablet against the innovator asenapine sublingual tablet conducted under fasting conditions in healthy male and female volunteersBioequivalence study on asenapine formulations.Schizophrenia in adultsOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveMental Health - SchizophreniaACTRN12613000650796Zenith Technology Corporation Limited36