None listed
Conditions
Interventions
Intervention1: DESIDUSTAT and ROSUVASTATIN CALCIUM: Frequency- every alternate date and once a day
Timepoint-Day 0,Day 2 ,Day 4 and Day 0,DAy 1,Day 2,Day 3,Day 4
Route-Oral
Dose-150mg and 10mg
Control
Sponsors
Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Healthy male subjects between 18 and 50 years (both inclusive) of age. 2)Male subjects must agree to use one of the contraception methods during the study. 3)Body weight > 50 kg and BMI within the range = 18.5 - 4)Capable of giving written informed consent, which includes compliance with protocol. 5)Ability to communicate effectively with study personnel.
Exclusion criteria
Exclusion criteria: 1. History of alcohol consumption or tobacco use or drug abuse within the past 1 year of enrollment or subject’s currently taking alcohol and/or tobacco products. 2. Presence or history of any of the disorders/disease within the past 3 months that might have impact on the clinical trial as per the investigator discretion i.e. a) cardiovascular, b) nervous system c) gastrointestinal, d) respiratory, e) any other major disorders 3. Difficulty with donating blood. 4. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. 5. Pulse rate less than 55/minute and more than 100/minute. 6. Any clinically significant laboratory or ECG findings during screening as per discretion of investigator. 7. Surgery within last 3 months or planned major surgery within next 3 months from the date of screening. Subjects not willing to use contraceptives till completion of the study. 8. Subjects who are found positive urine alcohol test and urine test for drug of abuse at the time of check in. 9. Difficulty in swallowing of tablet or capsule. 10. History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reactions. 11. Volunteers who have participated in any drug research study within past 3 months. 12. Volunteers who have donated one unit (350 ml) of blood in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare pharmacokinetics of Rosuvastatin alone Vs Rosuvastatin in combination of Desidustat.Timepoint: Day 0 and Day 4: Pre-dose, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.00 and 24.00 hours following IMP administration Day 2: Pre-dose and 5.0, hours following IMP administration. Day 3: Pre-dose Day 6: 48.00 hours following last IMP administration 72.00 hours following last IMP administration 96.00 hours following last IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Desidustat and Rosuvastatin administered to healthy subjects.Timepoint: Day 0 to Day 8 (EOS) | — |
Countries
India
Contacts
Public ContactDr Hardik Patel
Zydus lifesciences Ltd (Formerly Cadila Healthcare Ltd.)
Outcome results
None listed