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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To investigate bioequivalence of Test formulation of Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India against Reference formulation of Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden in healthy, adult, human Subjects following single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
研究概览
简要总结
Study Title: 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.
Protocol no. LBS-054-23/1, version no. 01 dated 12-Dec-23
Protocol amendment no. LBS-054-23/1/AM1 dated 22-Nov-24
Addendum to the protocol on 08-Dec-25
Test Formulation: Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India
Reference Formulation: Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden.
Route of administration: Oral
Primary objective
To investigate bioequivalence of Test formulation of Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India against Reference formulation of Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden in healthy, adult, human Subjects following single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
Secondary objective****s
To assess secondary PK parameters after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
To assess the safety and tolerability after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions in participating healthy Subjects.
Number of Subject: This study will be conducted using a two-stage design.
First stage: Forty [40] healthy, adult, male and/ or non-pregnant, non-lactating female, human Subjects will be enrolled in this study.
Second stage (if required): Based on the results of first stage sample size re-estimation will be done using statistical SOP. Based on this revised sample size, additional number of Subjects will be enrolled.
Male and if enrolled, female Subjects would be admitted in separate groups.
Subject Selection criteria: For all volunteers – Eligible through screening examinations, inclusion criteria and exclusion criteria. Only for eligible female volunteers – a negative serum ß-hCG test on the day of admission in period I and II [Defined by value of ≤ 5.7 mIU/mL].
Dosing: One tablet of ‘Test’ or ‘Reference’ IMP will be administered at scheduled time as per the randomization schedule with 240 ± 2 mL of water at ambient temperature after suitability of the Subject is decided by the qualified medical staff.
Pharmacokinetic blood sampling: The concentration of propiomazine, R-propiomazine and S-propiomazine will be determined in plasma separated from venous blood samples collected in K3EDTA vacutainers during period I and II as per following 25 time points under sodium vapor lamp**:** At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration.
Total blood loss: Six [6] mL blood will be collected at each sampling time point. The total blood loss in this study would exceed 347.0 ± 10 mL for male volunteers and 351.0 ± 10 mL for female volunteers [if enrolled]. This blood loss includes blood loss for general and additional screening, PK sampling, PSSA and discarded blood.
Washout period: At least 07 days and Total duration of the study is 11 days.
Study is designed to conduct in the two stage.
Update of the study:
1st stage of the study was conducted on 40 trial participant in which 18 female [Group I] and 22 male [Group II].
Group I: 06-Feb-2025 to 09-Feb-2025 [Period I] & 13-Feb-2025 to 16-Feb-2025 [Period II]
Group II: 10-Feb-2025 to 13-Feb-2025 [Period I] & 17-Feb-2025 to 20-Feb-2025 [Period II]
2nd Stage of this study was conducted on 46 trial participant in which 20 female [Group I] and 26 male [Group II].
Group I: 29-Dec-2025 to 01-Jan-2026 [Period I] & 08-Jan-2026 to 11-Jan-2026 [Period II]
Group II: 05-Jan-2026 to 08-Jan-2026 [Period I] & 12-Jan-2026 to 15-Jan-2026 [Period II]
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, Indian, male and/ or non-pregnant, non-lactating female, human volunteers aged from ≥ 18 to ≤ 45 years.
- •Voluntarily willing and capable to give written and signed informed consent prior to participation in the study.
- •Availability for the entire study period and willingness to adhere to the protocol and study requirements.
- •Willing to undergo pre- and post-study physical examinations and laboratory investigations.
- •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.
- •Having normal values or clinically insignificant abnormal values of investigations of clinical laboratory examination during screening.
- •12-lead supine ECG in resting position is within normal limits or showing clinically insignificant artifacts as per qualified medical staff.
- •Normal chest X-ray findings or findings that have no clinical correlation.
- •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.
- •Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocannabinoids, morphine, cocaine, benzodiazepine).
- •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.
- •Non-smokers [Definition – Those who do not have history of smoking or having quit smoking for more than 3 years].
- •Non-pregnant female Subject confirmed by negative serum β-hCG test [defined by value ≤ 5.7 mIU/mL] performed on the admission day.
- •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.
- •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
- •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.
- •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].
- •History or presence of renal function impairment established by serum creatinine 1.5 times or more of upper reference range.
- •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.
- •Irregular mealtimes, skipping meals, periods of fasting or dietary changes within last 3 months prior to enrollment in the study.
- •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.
- •Seropositive for VDRL, HIV or hepatitis B or C infection.
- •Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data, X-ray interpretation and full physical examination.
- •Vital sign abnormalities.
- •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.
- •Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug.
- •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.
- •Having a history of alcohol or substance abuse within the last 5 years.
- •Habit of chewing or inhaling nicotine-containing products.
- •Abnormal INR combined with clinical manifestation.
结局指标
主要结局
To investigate bioequivalence of Test formulation of Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India against Reference formulation of Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden in healthy, adult, human Subjects following single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
时间窗: Blood samples will be collected in K3EDTA vacutainers during period I and II (after 07 days of period I) as per following 25 time points i.e. At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration. Subject will be stay 48.000 hrs in both period.
次要结局
- 1. To assess secondary PK parameters after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.(2. To assess the safety & tolerability after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions in participating healthy Subjects.)
研究者
Dr Mukund Zarapkar
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.