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Bioequivalence test of ibuprofen sustained-release capsules in healthy subjects: a single center, randomized, open, single dose, two cycles, cross fasting and postprandial study

Bioequivalence test of ibuprofen sustained-release capsules in healthy subjects: a single center, randomized, open, single dose, two cycles, cross fasting and postprandial study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033629
Enrollment
Unknown
Registered
2020-06-07
Start date
2020-06-08
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Relieve pain from mild to moderate such as arthralgia, muscle , neuralgia, headache, migraine, toothache, dysmenorrhea,and fever caused by common cold or influenza. fever caused by common cold

Interventions

Fasting A group:TR
Fed A group:TR
Fed B group:RT

Sponsors

The Second Affiliated Hospital of Xingtai Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The subjects must give informed consent to the study before the trial, and sign the written informed consent voluntarily; 2) Gender: Chinese healthy male or female subjects, both male and female; 3) Aged 18-65 (including 18, excluding 65) years; 4) Weight: male >= 50.0kg, female >= 45.0kg; BMI [BMI = body weight (kg) / height 2 (m2)] in the range of 19.0-26.0kg/m2 (including boundary value); 5) The subjects can communicate with the researchers well ,understand and comply with the requirements of this study;

Exclusion criteria

Exclusion criteria: 1) Those who are enrolled in other clinical trials and take corresponding test drugs within 3 months before screening, or are participating in other clinical trials; 2) Physical examination, vital sign measurement, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, serum virology, etc.), 12-lead ECG test results the researchers judged abnormal clinical Meaning person; 3) Patients with a significant history of allergy, especially drug allergy 4)Liver, kidney, endocrine, cardiovascular, nerve, spirit, gastrointestinal tract (especially the history of peptic ulcer, gastrointestinal bleeding or perforation), lung, tumor, immune, skin, blood or metabolism disorders or any other diseases that the researchers think have clinical significance, or the history and other factors that will endanger the safety of the subjects or affect the research results; 5) Taking a special diet (including grapefruit, chocolate, caffeinated coffee or tea, or any caffeinated food or drink, etc.) or having vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before administration; 6) Those who were addicted to smoking (those who smoked more than 5 cigarettes per day in the first three months of the trial), those who were addicted to drinking (those who consumed more than 40 g of alcohol per week in the first three months of the trial (g = alcohol degree * ml * 0.8)), and those who can not guarantee to give up smoking and alcohol during the trial; 7) Alcohol breath test results greater than 0.0mg/100ml; 8) Previous drug use history, drug abuse history, or positive urine drug screening; 9) Those who have donated blood or lost blood equal to or more than 400ml within 3 months before screening, who have received blood transfusion or use blood products, or who intend to donate blood or blood components during the test or within 3 months after the end of the test; 10) For women who have unprotected sexual behaviors during pregnancy, lactation, or in the past two weeks, the subjects and their partners have pregnancy plans within 6 months after signing the informed consent to the end of the study, or are unwilling to take appropriate contraceptive measures even though they have no pregnancy plans; 11) Those who have sperm donation or egg donation plan between the trial period and the end of 6 months; 12) Who has taken any drug known to change liver enzyme activity within 4 weeks before taking the medicine; 13) Who has taken any medicine or health care product within 2 weeks before taking the medicine; 14) Significant changes in diet or exercise habits within 2 weeks before medication; 15) Those who have special requirements for diet and cannot accept unified diet; 16) Dysphagia; 17) It is difficult to take blood from vein, or it can't tolerate venipuncture, or it has a history of syncope; 18) The researcher believes that the subject has any reason that may affect the study or participate in the study that may have adverse effects on the subject.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC0-t;AUC0-8;

Countries

China

Contacts

Public ContactGuo Fengxue

The Second Affiliated Hospital of Xingtai Medical College

gfx0266@163.com+86 15132966386

Outcome results

None listed

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