oral food effect bio-availability study of Desidustat (ZYAN1) 50 mg and 100 mg tablet in healthy adult male and female subjects.

An open label, randomized, single-treatment, two-period, two- conditions (fed vs. fasting), two-sequence, crossover, single dose oral food effect bio-availability study of Desidustat (ZYAN1) 50 mg and 100 mg tablet in healthy adult male and female subjects. - ZYAN1 1004

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019163

Enrollment

108

Registered

2019-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Desidustat (ZYAN1): 50 mg in Plan I Intervention2: Desidustat (ZYAN1): 100 mg in Plan II Control Intervention1: Not Applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1)Having haemoglobin concentration in Males -12.8 â?? 14.9 g/dL and Females 11.3- 14.9 g/dL. 2)Male subjects must agree to use one of the contraception methods during the study. 3)Male: Body weight >= 50 kg; Female: Body weight >= 45 kg and BMI within the range >= 18.5 - 4)Capable of giving written informed consent, which includes compliance with protocol. 5)Females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited. 6)Ability to communicate effectively with study personnel.

Exclusion criteria

Exclusion criteria: 1)History or presence of alcoholism or drug abuse within the past 1 year. 2)History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products. 3)Difficulty with donating blood or Venepuncture procedure. 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 60/minute and more than 100/minute. 6)Any clinically significant laboratory or ECG findings during screening. 7)Surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening. 8)Subjects who have participated in any drug research study within past 3 months. 9)Subjects who have donated one unit (350 ml) of blood in the past 3 months. 10)Use of any over-the-counter (OTC), any prescription medications or alternative tradition of medicine (herbal medicines, homoeopathy, Siddha, Unani, etc.) within the 15 days or 5 half-lives of drug taken (whichever is longer), prior to receiving study drug that might have impact on the clinical trial as per the investigator discretion. 11)Male subjects not willing to use contraceptives till completion of the study. 12)Any clinically significant X-Ray abnormalities during screening. 13)Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in during both the periods.

Design outcomes

Primary

Measure	Time frame
To compare and evaluate the oral bioavailability of Desidustat (ZYAN1) tablet 50 mg and 100 mg in healthy, adult, human subjects under fasting and fed conditions. Timepoint: 0.33,0.66,1.00,1.33,1.66, 2.00,2.33,2.66,3.00,3.33, 3.66,4.00,4.50,5.00,5.50, 6.00,6.50,7.00,7.50,8.00, 10.00,12.00,16.00,24.00 hr, 48.00 hr and 72.00 hr	—

Secondary

Measure	Time frame
To monitor the safety of the subjects.Timepoint: Vital signs:-1.00, 2.00, 3.00, 6.00, 12.00, 24.00. Oral temperature:-Check-in,pre-dose and check-out. Clinical Examination:-check-in and check-out ECG at the time of screening.	—

Countries

India

Contacts

Public ContactDr Kevin Kansagra

Cadila Healthcare Limited

kevinkumarkansagra@zyduscadila.com02717665555

Outcome results