CTRI/2022/11/047283已完成不适用
A Randomized, Open Label, Balanced, Four Treatment, Four Period, Four-Sequence, Single Dose, Four way Crossover, Comparative Bioavailability Study of Testproduct T1: Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-Aqueous Topical Solution) (Dose: 1ml equivalent to 40 mg diclofenac sodium) and Testproduct T2: Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-Aqueous Topical Solution) (Dose: 2ml equivalent to 80 mg diclofenac sodium) ofTroikaa Pharmaceuticals Ltd., India with Reference product R1: Voveran Emulgel ofNovartis India Limited (Dose: 4 gm equivalent to 40 mg diclofenac sodium) andReference product R2: Voveran Emulgel of Novartis India Limited (Dose: 8 gmequivalent to 80 mg diclofenac sodium) in Normal, Healthy, Adult, Human Subjectsunder Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- PK Parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_% Extrap_obs, t1/2 and Kel.
研究概览
简要总结
This bioavailability study is planned to evaluate comparative bioavailability of Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-Aqueous Topical Solution) of Troikaa Pharmaceuticals Ltd., India with Voveran Emulgel sodium) of Novartis India Limited in 08 normal, healthy, adult, human subjects, under fasting conditions. Total expected duration of the study will be approximately 45 days from the day of admission of first period till end of the study.
Following PK parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_%Extrap_obs, t1/2 and Kel will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18 and 45 years (both inclusive).
- •Subjects weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with minimum of greater than equal to 55 kg weight.
- •Subjects with Haemoglobin greater than equal to 12.0 gm % at the time of screening.
- •Subjects with absence of clinically significant dermatological disease or condition or skin cancer.
- •Subjects with absence of open sores or large scars at application site or any type of skin lesions (such as swelling, rashes or abrasion).
- •Subjects with normal health as determined by personal medical history,clinical examination and laboratory examinations within the clinically acceptable range.
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •Subjects having clinically acceptable chest X-Ray (PA view).
- •Subjects having negative urine screen for drugs of abuse (includingamphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative Urine alcohol /alcohol breath test.
- •11.Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •For male Subjects: -Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by theinvestigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence.
- •Subjects should also not donate sperm during study period.
- •Subjects having negative urine pregnancy test at screening and negative serum beta-hCG Pregnancy test on admission day of period 01 (only for female subjects).
- •For Female Subjects: -Female 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 intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam.or -Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above or -Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •Hypersensitivity to Diclofenac or related class of drugs or any of its excipients or heparin.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing in period
- •Presence of alcoholism or drug abuse.
- •History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •Presence of skin conditions / infections and excessive hairs that might interfere with absorption of drug from application site like Lipoma, rash, scars, warts etc.
- •History or presence of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance.
- •Presence of excessive hair growth, recently shaved excessive oily, tattoo or any birthmark on dose application site.
- •History or presence of significant gastric and/or duodenal ulceration
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer or basal or squamous cell carcinoma.
- •Difficulty with donating blood.
- •Use of any prescribed medication or OTC medication including vaccine and vitamins during last 30 days prior to dosing in period
- •Major illness within past 3 months.
- •Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- •Consumption of xanthine-containing products, tobacco containing products, alcohol or alcoholic products for within 48.00 hours prior to dosing in period
- •Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to dosing of period
- •Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
- •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
结局指标
主要结局
PK Parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_% Extrap_obs, t1/2 and Kel.
时间窗: A total of 17 blood samples each of 6.0 ml will be collected during | each study period. | The pre-dose blood sample (0.00 hr) will be collected within one | hour prior to the dosing and post-dose blood samples will be drawn | at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, | 12.00, 14.00, 16.00, 20.00 and 24.00 hours following drug | administration in each period.
次要结局
- To monitor the safety and tolerability of subjects.(Vitals (Sitting Blood pressure and Radial pulse rate) will be measured pre-dose and at 3.00, 6.00 and 13.00 hours after dosing in each period.)
研究者
研究点 (1)
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