A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Favipiravir 200 mg Film-coated Tablets (AFAVIA) and Reference Product (AVIGAN TABLETS 200 MG) in Healthy Thai Volunteers under Fasting Conditions

Phase 1

• Conditions: Healthy Volunteers

• Registration Number: TCTR20210907001
• Lead Sponsor: Millimed Co., Ltd. (Branch)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-07
• Study Completion: 2021-12-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy Thai male or female subjects between the ages of 18 to 55 years.
2. Body mass index between 18.0 to 30.0 kg per m2.
3. Normal laboratory values including vital signs and physical examination for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases documented in
study files prior to enrolling the subject in this study.
4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives injectable progesterone progestin subdermal implants progesterone-releasing IUDs postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom diaphragm foams jellies or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
- Postmenopausal for at least 1 year or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
6. Male subjects who are willing or able to use effective contraceptive e.g. condom or
abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
7. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

Exclusion Criteria

1. History of hypersensitivity to favipiravir or any ingredient of the drug
2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo/hyperthyroidism, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo/hypertension), psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
3. Have high risk for coronavirus infection based on risk assessment questionnaire or
diagnosed as confirmed case of COVID-19
4. History about administration of first dose or second dose of COVID-19 vaccine
within 30 days prior to check-in in each Period.
5. History or evidence of gout
6. Investigation with blood sample shows hyperuricaemia, a serum urate level greater than 6.0 mg per dL in women and 7.0 mg per dL in men at screening laboratory test.
7. History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer
8. History of sensitivity to heparin or heparin-induced thrombocytopenia
9. History of problems with swallowing tablet or capsule
10. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
11. History of diarrhea or dehydration within 24 hours prior to check-in in each period
12. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
13. 12-lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the eligibility of subjects.
14. Investigation with blood sample shows positive test for HBsAg.
15. Abnormal liver function, more than or equal 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
16. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
17. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40 percent distilled spirits, such as rum, whisky, brandy etc.)
18. History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg percent BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for eligibility of subjects which must be 0 mg percent BAC.
19. History or evidence of habitual consume of tea, coffee, xanthine or ca

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary PK parameters : Cmax, AUC0-tlast and AUC0-inf. Secondary PK parameters : Tmax, t1/2, AUC0-tlast/AUC0-inf, AUC percent extrapolate, The terminal elimination rate constant and MRT 0.00 (pre-dose) and at 0.08, 0.16, 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.66, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 14.00 and 24.00 hours post-dose. Blood sampling schedule