Bioavailability study of Zolpidem Tartrate Sublingual Solutio
- Registration Number
- CTRI/2022/03/040997
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy human subjects aged between 18 and 45 years (both inclusive).
2.Subjects weight within clinically acceptable normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2 (both inclusive)) with minimum of 50 kg weight.
3.Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
4.Non-smoker and non-alcoholics.
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 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 until 6 months after the last dose of the study medication as judged by the investigator(s), such as Condom
with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm and blood during this time.
11.Subject having negative Urine Pregnancy test at screening and negative Serum β-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 Zolpidem 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, psychiatric, urogenital, dermatological or neurological disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 01 month prior to dosing in Period 01.
4. History or presence of alcoholism or drug abuse
5. History or presence of smoking.
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 liquid spray like sublingual solution.
12. Use of any prescribed medications and OTC medication Including vaccines, herbal drugs and vitamins within 30 days prior to admission in Period 01.
13. Major illness within past 03 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 grapefruit or grapefruit juice within 72.00 hours prior to dosing in period 01 and xanthine-containing products, tobacco containing products or alcohol or alcohol containing products for within 48.00 hours prior to admission in period 01.
16. Volunteer who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
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 Impotence, Altered (decreased) libido, Ejaculation disorders
20. History or presence of significant recent trauma.
21. Female Subjects who are lactating
22. Subjects who have family planning to have his own child during 06 months after the last dose of the study drug.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Plasma concentrations of Zolpidem will be measured using validated LC-MS/MS bioanalytical method <br/ ><br>Primary variables <br/ ><br>Cmax <br/ ><br>AUC0-t <br/ ><br>AUC0-infTimepoint: Pre-dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10, 12 and 16 hours
- Secondary Outcome Measures
Name Time Method The Plasma concentrations of Zolpidem will be measured using validated LC-MS/MS <br/ ><br>Secondary Variables <br/ ><br>Tmax, <br/ ><br>AUC_%Extrap_obs, <br/ ><br>t1/2 and <br/ ><br>Kel. <br/ ><br> <br/ ><br>PD paramenters through Digit Symbol Substitution Test <br/ ><br>(DSST)Timepoint: PK: Pre-dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10, 12 and 16 hours <br/ ><br> <br/ ><br>DSST: Pre dose and 6 min, 13 min, 21 min, 31 min, 40 min, 62 min after dosing ± 5 minutes of the scheduled time in each period