An Open Label, Balanced, Randomized, Single-Dose, Three-Treatment, Three-Sequence, Three-Period, bioavailability study of Granisetron Sublingual Solution 1% w/v of Troikaa Pharmaceuticals Ltd., India and two different reference products Reference-1 Graniset 1 mg film-coated tablets of Sun Pharma Laboratories Ltd., India and Reference-2 Granicip 3 mg/3 ml solution for injection of Cipla Ltd., India in healthy, adult, human subjects under fasting condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The Plasma concentrations of Granisetron will be measured using validated LC-MS/MS bioanalytical method
研究概览
简要总结
In recentyears, various methods have been developed to deliver therapeutic agentsthrough various transmucosal routes, to release a therapeutic amount of drug toa specific site and to maintain the desired therapeutic concentration. Theconventional dosage forms, such as tablets or injections have many drawbackssuch as poor bioavailability, poor solubility, quick breakdown of the drug invivo, and rapid loss of drug activity. These drawbacks can be overcome througha suitable delivery system, depending on the medical condition. The concept offast-dissolving films has become popular as a new delivery system. Severalapproaches have been developed and implemented, to improve the therapeuticoutcomes of Granisetron HCl. A transdermal patch and extended release SCinjection has been prepared to control the release and provide bettertherapeutic outcomes for the prevention of chemotherapy- induced N/V.Similarly, Troikaa Pharmaceuticals Ltd. has formulate granisetron sublingualsolution to improve the therapeutic efficacy and bioavailability by avoidingthe first pass metabolism. We hereby propose to conduct bioavailability studyto evaluate the pharmacokinetic behavior of Granisetron sublingual solution 1%w/v
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) 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 minimum of 50 kg weight.
- •3.Subjects with Haemoglobin ≥ 11.5 gm % 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 normal range.
- •5.Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •6.Subjects having clinically acceptable chest X-Ray (PA view).
- •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 willing to adhere to the protocol requirements and to provide written informed consent.
- •10.For male Subjects Subjects willing to follow approved birth control methods (a double barrier method) 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 11.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).
- •12.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 Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •1.Hypersensitivity to Granisetron 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 1 month prior to dosing in period
- •4.Presence of significant alcoholism or drug abuse.
- •5.History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •7.History or presence of significant gastric and/or duodenal ulceration.
- •8.History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •9.History or presence of cancer or basal or squamous cell carcinoma.
- •10.Difficulty with donating blood.
- •11.Difficulty in swallowing solids like tablets or capsules.
- •12.Use of any prescribed medication or OTC medication during last 30 days prior to dosing in period
- •13.Major illness within past 3 months.
- •14.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.
- •15.Consumption of xanthine-containing products, tobacco containing products or alcohol or alcoholic products for within 48 hours prior to dosing in period
- •16.Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to dosing of period
- •17.Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •18.History or presence of significant easy bruising or bleeding.
- •19.History or presence of significant recent trauma.
- •20.Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •Female subjects who are currently pregnant or breast feeding.
结局指标
主要结局
The Plasma concentrations of Granisetron will be measured using validated LC-MS/MS bioanalytical method
时间窗: Primary variables | Cmax, AUC0-t, AUC0-inf | 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hr
Primary variables
时间窗: Primary variables | Cmax, AUC0-t, AUC0-inf | 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hr
Cmax AUC0-t
时间窗: Primary variables | Cmax, AUC0-t, AUC0-inf | 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hr
AUC0-inf
时间窗: Primary variables | Cmax, AUC0-t, AUC0-inf | 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hr
次要结局
- Tmax AUC_%Extrap_obs t1/2(Kel)