| CTRI Number |
CTRI/2019/05/019163 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
oral food effect bio-availability study of Desidustat (ZYAN1) 50 mg and 100 mg tablet in healthy adult male and female subjects. |
|
Scientific Title of Study
|
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. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| ZYAN1 1004 Ver.02 10th July 2018 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Hardik Patel |
| Address |
Zydus Research Centre, Cadila Healthcare Limited
Survey No. 396/403,Opp Sarvotam Hotel,Near Nova Petrochemicals,Sarkhej-Bavla N.H. No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Hardik.Patel@zyduscadila.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Kevin Kansagra |
| Address |
Zydus Research Centre, Cadila Healthcare Limited Survey No. 396/403, Opp. Sarvotam Hotel, Near Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Kevin Kansagra |
| Address |
Zydus Research Centre, Cadila Healthcare Limited Survey No. 396/403, Opp. Sarvotam Hotel, Near Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Zydus Research Centre, Cadila Healthcare Limited Survey No. 396/403, Opp. Sarvottam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Zydus Research Centre |
| Address |
Cadila Healthcare Limited Survey No. 396/403, Opp. Sarvottam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat, India.Telephone No. 02717-665555;Fax No.02717- 665355 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hardik Patel |
Zydus Research Centre |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. N. 8A, Moraiya, Ahmedabad-382213
Ahmadabad
|
02717665555
Hardik.Patel@zyduscadila.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee C/o Sangini Hospital, First Floor, Santorini Square, b/h Abhishree Complex, Opp. Star Bazar, Nr.Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desidustat (ZYAN1) |
100 mg in Plan II |
| Intervention |
Desidustat (ZYAN1) |
50 mg in Plan I |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Having haemoglobin concentration in Males -12.8 – 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 - < 30 kg/m2.
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
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.
|
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 Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the subjects. |
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. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
23/12/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Brief Summary
|
A study 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. |
