Status Approved
First Submitted Date
2021/01/18
Registered Date
2021/03/02
Last Updated Date
2021/02/22
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005943 |
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Unique Protocol ID | 2019-09-056 |
Public/Brief Title | Huons’s "Ollofree Tab" (Olopatadine HCl 5mg) and Kyowa Kirin Korea’s "Alerac Tablet 5 mg" (Olopatadine HCl 5 mg) for biological equivalence evaluation, group 2, cross test |
Scientific Title | Open, Randomization, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-Test in Healthy Adults for Bioequivalence Assessment in healthy adults to evaluate the bioequivalence between Huons’s Ollofree Tab (Olopatadine HCl 5mg) and Kyowa Kirin Korea’s Alerac Tablet 5 mg (Olopatadine HCl 5 mg) |
Acronym | RDG-19015_BE |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CNUH 2019-09-56 |
Approval Date | 2019-10-18 |
Institutional Review Board Name | Chungnam National University Hospital Institutional Review Board |
Institutional Review Board Address | 282, Munhwa-ro, Jung-gu, Daejeon |
Institutional Review Board Telephone | 042-280-8715 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hong Jang hee |
Title | Prof. |
Telephone | +82-42-280-6940 |
Affiliation | Chungnam National University Hospital |
Address | Chungnam National University Hospital Clinical Trials Center 282 Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Kore |
Contact Person for Public Queries | |
Name | Kim Jae hoon |
Title | DM |
Telephone | +82-42-280-6852 |
Affiliation | Chungnam National University Hospital |
Address | Chungnam National University Hospital Clinical Trials Center 282 Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Kore |
Contact Person for Updating Information | |
Name | Kim Jae hoon |
Title | DM |
Telephone | +82-42-280-6852 |
Affiliation | Chungnam National University Hospital |
Address | Chungnam National University Hospital Clinical Trials Center 282 Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Kore |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-12-06 Actual | |
Target Number of Participant | 32 | |
Primary Completion Date | 2020-01-02 , Actual | |
Study Completion Date | 2020-01-02 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chungnam National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-12-06 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Huons |
Organization Type | Pharmaceutical Company |
Project ID | 2019-09-056 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Huons |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | After a single dose of a comparator or a test drug containing 5 mg of Olopatadine HCl, the pharmacokinetic evaluation variables of the two formulas are compared with AUC0-t and Cmax to assess biological equivalence, and to assess abnormal reactions, pathologic drugs, electrocardiography to Evaluate safety items. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1 |
Intervention Model | Cross-over |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | Single oral administration of reference drug(VIVIANT TAB.20 mg) under fasting conditions and single oral dose of test drug(Vivantzheng 20 milligrams) under fasting conditions 14 days apart. |
Number of Arms | 2 |
Arm 1 |
Arm Label Sequence A |
Target Number of Participant 16 |
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Arm Type Others |
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Arm Description Single oral dose of reference drug(Alerac Tablet 5 mg, Olopatadine HCl 5 mg) under fasting conditions and single oral administration of test drug(Ollofree Tab. Olopatadine HCl 5 mg) under fasting conditions 14 days apart. |
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Arm 2 |
Arm Label Sequence B |
Target Number of Participant 16 |
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Arm Type Others |
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Arm Description Single oral dose of test drug(Ollofree Tab. Olopatadine HCl 5 mg) under fasting conditions and single oral administration of reference drug(Alerac Tablet 5 mg, Olopatadine HCl 5 mg) under fasting conditions 14 days apart. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (L00-L99)Diseases of the skin and subcutaneous tissue (L29.9)Pruritus, unspecified Pruritus |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
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Description 1)Healthy adult volunteers over the age of 19 at screening. 2)Subject who weight was ≥ 55 kg and ideal body weight (IBW) was within ±20% - Ideal Body Weight (IBW, kg) = (Height(cm) - 100) × 0.9 3)Subject who don’t have congenital or chronic disease and any pathologic sign or symptom from medical check-up. 4)Subject who be within normal range by clinical laboratory results such as hematology test, blood chemistry test, urine test, etc. 5)Subject who be confirmed not to be pregnant through pregnancy test. 6)Subject who be informed of and completely understood this clinical trial and signed the written informed consent for voluntary participation. |
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Exclusion Criteria |
1)Subject who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine (Especially patients with type 1 diabetes or diabetic ketoacidosis, diabetic pre-coma), urologic, psychiatric, musculoskeletal, immunologic, otorhinolaryngological, and cardiovascular diseases. 2)Subject with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy or repair of a hernia), which can influence the absorption of the study drug. 3)Patient with prostatic hypertrophy or glaucoma. 4)Subject who laboratory findings under any of the followings. - AST, ALT > UNL(upper normal limit) x 2.0 - eGFR < 60 mL/min/1.73m2 from Modification of Diet in Renal Disease Study 5)Subject who systolic blood pressure (SBP) < 100 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 90 mmHg or < 60 mmHg or pulse rate (PR) ≥ 100 /min in sitting position. 6)Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes within 30 day before the first study drug administration. 7)Subject who took central nervous system depressants drugs or Anticholinergic drugs within 30 days before the first study drug administration and subject whose other conditions are judged by investigators as not appropriate for this clinical trial could not participate in this study. 8)Subject who have participated in bioequivalence studies or other clinical trials within 6 months of the first day of study drug administration. 9)Subject who donated whole blood within 2 months or blood components within 1 month before the first administration, or who received blood transfusion within 1 month before the first administration. 10)Subject who has a history or presence of regular consumption exceeding an average weekly intake of > 21 units of alcohol in recent 6 months prior to the Screening visit or unable to refrain from drinking during within 48 hours prior to the study drug administration and until last pharmacokinetic sampling.(250 ml of beer (5%)) = 10 g, soju (20%) 1 cup (50 ml) = 8 g, wine (12%) 1 cup (125 ml) = 12 g) 11)Smokers with an average daily smoking amount exceeding 10 cigarettes per day in recent 3 months prior to the Screening visit or unable to refrain until last pharmacokinetic sampling from 48 hours prior to administration of study drug. 12)lactating women. 13)Subejct who do not agree to use medically acceptable methods* of contraception from first study drug administration to 7 days after last administration of study drug. *Medically acceptable methods: combination of two or more of the following (intrauterine devices (IUD, IUS), vasectomy, fallopian tube ligation and blocking contraception (male condom, female) condom) or a combination of spermicide and two combinations of blocking contraception. 14)Uncontrolled genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 15)Subject with known hypersensitivity or history of allergy to the study drug containing Yellow No. 5 (Sunset Yellow FCF, Sunset Yellow FCF) 16)Those who are not willing or able to abide by the lifestyle guidelines described in study plan. 17)Subject who, in addition to the exclusion criteria above, has determined that the examiner is not suitable for participation in the bioequivalence test due to clinical laboratory test results or other reasons |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Bio-Equivalence | |
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Primary Outcome(s) 1 | ||
Outcome | Area under the Curve 0-t |
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Timepoint | Blood samplings up to 24 hours post-dose in each period |
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Primary Outcome(s) 2 | ||
Outcome | Concentration max |
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Timepoint | Blood samplings up to 24 hours post-dose in each period |
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Secondary Outcome(s) 1 | ||
Outcome | Area under the Curve infinite |
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Timepoint | Blood samplings up to 24 hours post-dose in each period |
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Secondary Outcome(s) 2 | ||
Outcome | Terminal half-life |
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Timepoint | Blood samplings up to 24 hours post-dose in each period |
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Secondary Outcome(s) 3 | ||
Outcome | The time it takes a drug to reach the maximum concentration |
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Timepoint | Blood samplings up to 24 hours post-dose in each period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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