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A Single-site, Randomized, Open-label, Three-cycle-crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of the Calcium-containing Phosphate Binder Calcium Acetate Tablets and the Non-calcium-containing Phosphate Binder Sevelamer Carbonate Tablets on Desidustat Tablets in Healthy Subjects

A Single-site, Randomized, Open-label, Three-cycle-crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of the Calcium-containing Phosphate Binder Calcium Acetate Tablets and the Non-calcium-containing Phosphate Binder Sevelamer Carbonate Tablets on Desidustat Tablets in Healthy Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072509
Enrollment
Unknown
Registered
2023-06-15
Start date
2023-07-03
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Renal anemia

Interventions

Group 1:Group 1:A-B-C A for Desidustat tablets 150mg
B for Desidustat tablets150mg + Sevelamer Carbonate tablets (2400mg, tid, 6 times in a row)
C for Desidustat tablets150mg + Calcium Acetate tablets (2001mg, tid, 6 times in a row)
Group 2:Group 2: B-C-A A for Desidustat tablets 150mg
Group 3:Group 3: C-A-B A for Desidustat tablets 150mg
Group 4:Group 4: A-C-B A for Desidustat tablets 150mg
Group 5:Group 5: B-A-C A for Desidustat tablets 150mg
Group 6:Group 6: C-B-A A for Desidustat tablets 150mg

Sponsors

Henan Privince Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The subjects must give informed consent , fully understand the content, process and possible adverse reactions of the study, and voluntarily sign a informed consent form before the study begins; 2. The subject can communicate well with the investigator and complete the study in accordance with the protocol; 3. Age: 18 ~ 45 years old (including boundary value); 4. Gender: male or female; 5. Weight: Male weight = 50kg, female weight = 45kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] is within the range of 19.0 ~ 26.0kg/m2 (including the boundary value).

Exclusion criteria

Exclusion criteria: 1. Those who have participated in any other clinical trials within 3 months before signing the informed consent form; (inquiry + online screening) 2. Those with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to drugs, food such as milk and pollen), those known to be allergic to the components of Desidustat tablets, Sevelamer Carbonate tablets or Calcium Acetate, or hypoxia-inducible factor-prolyl hydroxylase inhibitors; (inquiry) 3. Those with the following diseases with clinical significance in the past (including but not limited to respiratory system, cardiovascular system, digestive system, blood system, endocrine system, immune system, skin and mucous membranes, mental nervous system, ENT and other related diseases), or determined by the investigator who still have clinical significance; (inquiry) 4. Those who have a history of needle fainting/blood fainting or venipuncture intolerance; (inquiry) 5. Those who have done the surgery which the investigator judges will affect drug absorption, distribution, metabolism, and excretion before signing the informed consent form with 3 months, or those who plans to have a surgery during the trial; (inquiry) 6. Regular drinkers within 6 months before signing the informed consent, drinking more than 14 units of alcohol per week (1 unit = 360mL beer with 5% alcohol content or 45mL spirits with 40% alcohol content or 150mL alcohol 12% wine); (inquiry) 7. Those who drunk within 14 days before signing the informed consent form or who do not agree to stop drinking alcohol or taking alcoholic food and beverages (such as: egg yolk pie, alcoholic chocolate) during the trial to 3 days after the end of the trial; (inquiry) 8. Those who have used soft drugs (such as marijuana) within 3 months before signing the informed consent form or hard drugs (such as morphine, methamphetamine, ketamine, methylenedioxyamphetamine, four Hydrocannabinolic acid) within 1 year prior to the trial ; (inquiry) 9. Those who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form or who can not give up smoking during the hospitalization; (inquiry) 10. Those who have been vaccinated within 2 weeks before signing the informed consent form or plan to be vaccinated during the trial; (inquiry) 11. Those who have used drugs (including prescription drugs, over-the-counter drugs, traditional Chinese medicine preparations, functional vitamins) , health care products, etc., within 2 weeks before signing the informed consent except that the investigator judged that the drug has been washed out, and would not interfere with the trial;(inquiry) 12. Those who have used any drugs that inhibit or induce liver drug enzymes within 30 days before signing the informed consent (such as: inducers-barbiturates, entecavir, phenytoin, phenobarbital, glucocorticoids; inhibitors-SSRI antidepressants drugs, omeprazole, cimetidine, diltiazem, verapamil, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, etc.); (inquiry) 13. Those whose amount of blood transfusion/blood loss/blood donation reached 200mL and above within 3 months before signing the informed consent (except for female menstrual period bleeding), those who donated 2 therapeutic doses of platelets within 1 month (1 therapeutic dose=12U platelets), those who received blood transfusion or use blood products, or those who plans to donate blood within 3

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic;

Secondary

MeasureTime frame
Safety;

Countries

China

Contacts

Public ContactChen Jianshe

Henan Privince Hospital of Traditional Chinese Medicine

chenjiansheyin@126.com+86 371 6090 5757

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026