A randomized, open-label, two-treatment, two-period, two- sequence, single-dose,balanced, crossover, comparative bioavailability study of Dynapar QPS Plus of TroikaaPharmaceuticals Ltd., India with Volini Aerosol Spray of Sun Pharmaceutical IndustriesLtd, India 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
- 8
- 试验地点
- 1
- 主要终点
- PK parameters:
研究概览
简要总结
This study isplanned to compare bioavailability ofDynapar QPS Plus of Troikaa Pharmaceuticals Ltd., India with Volini AerosolSpray of Sun Pharmaceutical Industries Ltd, in healthy, adult, human subjectsunder fasting conditions.
Total expected durationof the study will be approximately 17-18 days from the day of admission offirst period till end of the study.
Following PKparameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_%Extrap_obs, t1/2 and Kel will be measured.
This is DCGI approvedproduct and We have already registered phase III clinical trial of Dynapar QPSPlus with CTRI registration number CTRI/2011/091/000001 [Registered on:11/01/2011] with title of study:
A randomized, two arm, open label, active controlled,multicentric clinical study to evaluate the efficacy and safety of atopicalformulations of diclofenac (2.32% w/v solution) with Methyl Salicylate 10% w/vand Menthol 5% w/v versus a topical Diclofenac Gel (1.16%w/w) with Methyl Salicylate 10% w/w and Menthol 5% w/w in acute low back acheand sprains.
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
- •1 Subjects aged between 18 and 45 years (both inclusive) of both gender.
- •2 Subjects weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with greater than equal to 50 kg weight.
- •3 Subject with hemoglobin level greater than equal to 11.5 gm percent at the time of screening.
- •4 Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
- •5 Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •6 Subjects having clinically acceptable chest X-Ray (PA view), if taken.
- •7 Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •8 Subjects having negative Urine alcohol /alcohol breath test.
- •9 Subjects who are Non-smokers.
- •10 Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •11 For male Subjects: Subjects willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence.
- •Subjects should also not donate sperm during study period.
- •12 Subjects having negative urine pregnancy test at screening and negative serum Beta-hCG Pregnancy test on admission day of period
- •(For female subject).
- •13 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 plus diaphragm, condom plus spermicidal or foam.
- •Or Postmenopausal for at least 1 year, or if less than 1 year, then 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
- •1 Hypersensitivity to Diclofenac or related class of drugs or any of its excipients or heparin.
- •2 History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- •3 Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission of period-
- •4 Presence of alcoholism or drug abuse.
- •5 History or presence of asthma, urticaria or other significant allergic reactions.
- •6 History or presence of significant gastric and/or duodenal ulceration.
- •7 History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •8 History or presence of cancer or basal or squamous cell carcinoma.
- •9 Difficulty with donating blood.
- •10 Use of any prescribed medication or OTC medication including vaccine, vitamins and herbal remedies during last 30 days prior to admission of period
- •11 Major illness within past 3 months.
- •12 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.
- •13 Consumption of xanthine-containing products, tobacco containing products, alcohol or alcoholic products for within 48.00 hours prior to admission of period
- •14 Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period
- •15 Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •16 History or presence of significant easy bruising or bleeding.
- •17 History or presence of significant recent trauma.
- •18 Any contraindication to cannulation or blood sampling.
- •19 Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •21 Subjects who have Bruises, damaged skin, eczema or wounds on the application site, or the application site inappropriate for applying the IMP as per PI discretion.
结局指标
主要结局
PK parameters:
时间窗: A total of 19 blood samples will be collected during each study period. | The pre-dose blood sample of 4.0 mL (0.00 hour) will be collected within one hour prior to scheduled time of dosing in each study period. | The post-dose blood samples of 4.0 mL each 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, 18.00, 20.00, 22.00 & 24.00 hours after dosing in each study period.
Cmax, AUC(0-t), AUC(0-∞),
时间窗: A total of 19 blood samples will be collected during each study period. | The pre-dose blood sample of 4.0 mL (0.00 hour) will be collected within one hour prior to scheduled time of dosing in each study period. | The post-dose blood samples of 4.0 mL each 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, 18.00, 20.00, 22.00 & 24.00 hours after dosing in each study period.
Tmax, AUC_% Extrap_obs, t1/2 & Kel.
时间窗: A total of 19 blood samples will be collected during each study period. | The pre-dose blood sample of 4.0 mL (0.00 hour) will be collected within one hour prior to scheduled time of dosing in each study period. | The post-dose blood samples of 4.0 mL each 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, 18.00, 20.00, 22.00 & 24.00 hours after dosing in each study period.
次要结局
- To monitor the safety & tolerability of subjects(Vital signs (blood pressure & radial pulse rate) will be measured before)