Comparative pharmacokinetic exposure evaluation of two formulations of Remdesivir in healthyadult human male subjects.

Not Applicable

• Registration Number: CTRI/2021/04/033072
• Lead Sponsor: upin Limited Research Park

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy, human male subjects aged between 18 and 45 years (inclusive of both).

2. Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and body mass not less than 50.00 kg.

3. Subjects in normal health as determined by personal medical history,clinical examination including vital signs and clinically acceptable

results of laboratory examinations (including serological tests).

4. Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.

5. Subjects having a normal or clinically not significant chest X-Ray (P/A view).

6. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).

7. A negative alcohol urine test result.

8. A negative COVID-19 RTPCR result before each check in.

8. Subject able to communicate effectively and provide written informed consent.

9. Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.

10.Subjects that can provide adequate evidence of their identity.

11. Male agreeing to use appropriate contraceptive measures like Double Barrier method (Condom).

12. Availability of volunteer for the entire study duration.

13. Ability to fast for at least 14.00 hours and consume standard meals.

Exclusion Criteria

1. Known hypersensitivity to Remdesivir or related drugs or any component of this medication.

2. Incapable of understanding the informed consent information.

3. History or presence of significant cardiovascular, pulmonary, hepatic, renal (estimated e GFR < 60mL/min), gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the

study

5. History or presence of alcoholism or drug abuse.

6. History or presence of asthma, urticaria or other allergic reactions.

7. History or presence of gastric and/or duodenal ulceration.

8. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.

9. History or presence of cancer

10. Difficulty with donating blood.

11. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal Products

(including herbal remedies) during the week prior to study initiation and throughout the study.

12. Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study.

13. Subject consumed tobacco/ tobacco containing products, pan or pan masala, gutkha, masala ( containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.

14. Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas,

colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.

15. Major illness during the 90 days before screening.

16. Participation in a drug research study within 90 days of screening.

17. Donation of blood within 90 days of screening.

18. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.

19. History or presence of easy bruising or bleeding.

20. Abnormal diet pattern for whatever reason ( e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.

21. Male volunteer willing to donate sperms during the study till 09 days after the completion of study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC0-tTimepoint: Pre dose and at 0.25 (15 minutes), 0.33 (20 minutes), 0.50 <br/ ><br>(30 minutes), 0.67 (40 minutes), 1.00 (60 minutes), 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, <br/ ><br>6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing.

Secondary Outcome Measures

Name	Time	Method
Cmax, T max, AUC0-â??, AUC _%Extrap_obs, <br/ ><br>Ke1 and t½.Timepoint: Pre dose and at 0.25 (15 minutes), 0.33 (20 minutes), 0.50 <br/ ><br>(30 minutes), 0.67 (40 minutes), 1.00 (60 minutes), 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, <br/ ><br>6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing.