An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover, Comparative Bioavailability Study of Ketorolac Tromethamine Sublingual Tablet 10 mg of Troikaa Pharmaceuticals Ltd., India and Ketorol – DT (Ketorolac Tromethamine Dispersible Tablet 10 mg) of Dr. Reddys Laboratories Ltd., India in healthy, adult, human subjects under fed condition.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- PK parameters:
研究概览
简要总结
This is an Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover, Comparative Bioavailability Study of Ketorolac Tromethamine Sublingual Tablet 10 mg of Troikaa Pharmaceuticals Ltd., India and Ketorol – DT
(Ketorolac Tromethamine Dispersible Tablet 10 mg) of Dr. Reddy’s Laboratories Ltd., India in healthy, adult, human subjects under fed condition.
Total expected duration of the study will be of at least 10 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
- 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
- •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 per m2) (both inclusive) with minimum of 50 kg weight.
- •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) if taken.
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative Urine alcohol /alcohol breath test.
- •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 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.
- •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 plus diaphragm, condom plus 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 Ketorolac Tromethamine, aspirin or NSAIDs or related class of drugs or any of its excipients.
- •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 1 month prior to dosing in period
- •Presence of significant alcoholism or drug abuse.
- •History or presence of significant smoking.
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •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.
- •Difficulty in swallowing solids like tablets or capsules.
- •Use of any prescribed medication or OTC medication and vaccine during last 30 days prior to admission 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 caffeine or xanthine-containing products, tobacco containing products or alcohol or alcoholic products within 48 hours prior to admission in period
- •Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to admission 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.
- •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:
时间窗: 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 0.083, | 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, | 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours following drug | administration in each period.
Cmax, AUC(0-t), AUC(0-∞),
时间窗: 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 0.083, | 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, | 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours following drug | administration in each period.
Tmax, AUC_% Extrap_obs, t1/2 & Kel
时间窗: 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 0.083, | 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, | 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours following drug | administration in each period.
次要结局
- Following parameters will be measures as safety outcomes:(1. blood pressure)
研究者
Dr Imran Ghanchi
Veeda Clinical Research Ltd.