Bioavailability study to evaluate the pharmacokinetics safety and tolerability of Granisetron Sublingual Solution 1%
- Registration Number
- CTRI/2021/09/036239
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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).
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 01.
4.Presence of significant alcoholism or drug abuse.
5.History or presence of significant smoking (more than 10 cigarettes or beedis/day).
6.History or presence of asthma, urticaria or other significant allergic reactions.
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 01.
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 01.
16.Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to dosing of period 01.
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.
21. Female subjects who are currently pregnant or breast feeding.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Plasma concentrations of Granisetron will be measured using validated LC-MS/MS bioanalytical method <br/ ><br>Primary variables <br/ ><br>Cmax AUC0-t <br/ ><br>AUC0-infTimepoint: Primary variables <br/ ><br>Cmax, AUC0-t, AUC0-inf <br/ ><br>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
- Secondary Outcome Measures
Name Time Method Tmax AUC_%Extrap_obs t1/2 <br/ ><br>KelTimepoint: 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