Rosacea
Conditions
Interventions
Sequence Group 1:Doxycycline capsules, specification: 40mg/capsule
A single oral dose of 40 mg will be taken in each period. Each participant will receive two doses in the trial,following the sequence of test formulation (T), reference formulation (R).
Sequence Group 2:Doxycycline capsules, specification: 40mg/capsule
A single oral dose of 40 mg will be taken in each period. Each participant will receive two doses in the trial,following the sequence of reference formulation (R),test formulation (T).
Sponsors
Hangzhou Combak Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 2.Able to complete the trial in compliance with the protocol; 3.Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 6 months after the last scheduled visit; 4.Males and females >=18 and <=55 years old; 5.At least 60 kg for males, 50 kg for females, with a Body Mass Index (BMI) = Weight/Height^2 (kg/m^2) between 19.0-26.0 kg/m^2, inclusive.
Exclusion criteria
Exclusion criteria: 1.A history of chronic or serious cardiac, hepatic, renal, digestive tract, hematopoietic system, nervous system, mental and metabolic disorders, etc.; 2.With >= 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 3.Allergic to two or more substances, or specific allergy history (e.g. asthma, allergic rhinitis, urticaria, eczema), or allergic to the drug components and its analogues; 4.A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine); 5.Blood donation or massive blood loss ( >= 400 mL) within 3 months before the initial administration; Or any blood donation plan from screening until 1 month after the last administration; 6.A history of dysphagia, or any gastrointestinal disease which may affect the drug absorption; 7.A history of pseudotumor cerebri (benign intracranial hypertension) (clinical manifestations can be headache and blurred vision); 8.A history of excessive Candida growth in the past or who are susceptible to Candida infection; 9.Creatinine clearance rate < 80 ml/min; 10.Those who have experienced Clostridium difficile associated diarrhea within 30 days before the initial administration; 11.Intake of any drugs that inhibit or induce liver drug enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, etc.; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, etc.); penicillin, methoxyflurane, bismuth preparations, acid suppressants, antacids, iron-containing preparations, retinoid and anticoagulants drugs within 30 days before the initial administration; 12.Any prescription medication within 14 days before the initial administration; 13.Any over-the-counter (OTC) medication or herbal medicine or health supplementary within 7 days before the initial administration; 14.Consumption of any special diets or food items (such as grapefruit), or strenuous exercise engagement, or other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration; 15.Participation in other drug clinical trials within 90 days before the initial administration; 16.Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram and laboratory tests (biochemistry, blood glucose, hematology, urinalysis, serum pregnancy test (females only), and viral tests (HBV, HCV, HIV, syphilis), etc.); 17.Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before the initial administration; 18.Consumption of any products containing alcohol within 24 h before the initial administration, or a positive result of the alcohol breath test; 19.A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial; 20.A positive result of the pregnancy test, or in lactation during screening or the test period for female participants; 21.Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood; 22.Special requirements and unable to follow the unified diet; 23.Unable to participate in this trial for participants’ own reasons; 24.Other conditions in which participants are not suitable for the trial determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-8 of plasma Doxycycline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, t1/2, AUC_%Extrap of Doxycycline in plasma; | — |
Countries
China
Contacts
Public ContactXiao Guomin
Hangzhou Combak Hospital
Outcome results
None listed