Comparative bioavailability study of TRC041266 Powder with TRC4186 Tablet in Healthy Human Subjects.

Phase 1

Completed

• Registration Number: CTRI/2018/08/015226
• Lead Sponsor: Torrent Pharamceutical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-09-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1.Male and/or female subjects aged 18-65 years (both inclusive).

2.Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with minimum weight of 50 kg.

3.Volunteer willing to provide written informed consent.

4.Ability to adhere to the study restrictions and assessments schedule

Exclusion Criteria

1. Inability to communicate or co-operate.

2. History of angina, myocardial infarction (MI) or stroke within last 3 months prior

to screening.

3. Volunteers suffering from any chronic illness such as arthritis, asthma etc.

4. History of pre-existing bleeding disorder.

5. Clinically relevant abnormal physical findings at the screening examination,

which would interfere with the objectives of the study.

6. Clinically significant abnormalities in the results of the clinical laboratory tests (at

screening or check-in day (i.e. Day-0)).

7. Clinically significant abnormal ECG (at screening), 2D Echo or Chest X-ray.

8. Pregnant or lactating women or female subjects who are of childbearing potential

and who are neither surgically sterilized nor willing to use reliable contraceptive

methods {i) bilateral tubal occlusion; ii) vasectomised partner and iii) sexual

abstinence iv) barrier method of contraception} and/or female volunteer with

positive urine pregnancy test.

9. Smokers who are unable to stop tobacco consumption during each study period, or

smokers who smokes >10 cigarettes (or equivalent) per Day during last 3 months

prior to Day 1.

10. Positive for HIV, HCV and HbsAg.

11. History of significant blood loss due to any reason, including blood donation in

the past 3 months; or the total blood loss in the last 3 months, including for this

study, exceeds 450 ml.

12. Participation in any study within past 3 months

13. Addiction to alcohol or history of alcohol or drug abuse

14. Intake of hepatic microsomal enzyme inducer/inhibitor drugs in the period within

3 months prior to the first dose of study drug

15. History of consumption of prescribed medication since last 14 days or OTC

medication/ herbal remedies since last 7 days before beginning of the study.

16. Volunteer found to be positive for breath alcohol test.

17. History of malignancy

18. Volunteer found to be positive for opiate, tetrahydrocannabinoid, amphetamine,

barbiturates, benzodiazepines, cocaine based on urine test.

19. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and

diastolic blood pressure less than 60 mmHg or more than 89 mmHg.

20. Pulse rate less than 60/minute or more than 100/minute.

21. Oral temperature less than 95°F or more than 98.9°F.

22. Respiratory rate less than 10/minute or more than 20/minute.

23. History of hypersensitivity reaction/allergy to the investigational product or any

drug chemically similar to the drug under investigation or any of the excipients.

24. Recent History of kidney or liver dysfunction.

25. Volunteers suffering from any psychiatric (acute or chronic) disorder.

26. Existence of any surgical or medical condition, which, in the judgment of the

chief investigator and/or clinical investigator/physician, might interfere with the

absorption, distribution, metabolism or excretion of the drug or likely to

compromise the safety of volunteers

27. Volunteers with left ventricular ejection fraction (LVEF) < 55%

Study & Design

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

Primary Outcome Measures

Name	Time	Method
1. To compare the pharmacokinetics of TRC041266 <br/ ><br>powder with TRC4186 tablet <br/ ><br>2. To evaluate the effect of food on the pharmacokinetics <br/ ><br>of TRC041266 PowderTimepoint: Pre-dose, and at 0.25, <br/ ><br>0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, <br/ ><br>8.00, 12.00, 24.00, 36.00 and 48.00 hours post dose

Secondary Outcome Measures

Name	Time	Method
I. To evaluate the safety and tolerability of TRC041266 Powder in healthy human subjects. <br/ ><br> <br/ ><br>II. To study the impact of drug administration by means of comparing bioavailability of TRC041266 in fasting condition while administering it with water and with low fat milk.Timepoint: Vital signs : At enrolment, pre-dose, 1.00, 3.00, <br/ ><br>7.00 and 24.00 hours post dose, discharge, post <br/ ><br>study safety evaluation. Physical examination : Enrolment, at discharge, post study follow up. <br/ ><br>Well-being of subject: Pre-dose, 1.00, 3.00, 7.00 and 24.00 hours post-dose. ECG measurement: Pre-dose, 2.00, 4.00, 8.00, 24.00 hours post dose, discharge, at post study follow up. Clinical Laboratory Tests: Pre (Screening), enrolment, check-out,Post Study safety evaluation.