Bioequivalence study of methyldopa 250 mg tablets (Dopamet) produced by PT Actavis Indonesia in comparison with the comparator product (Aldomet® 250 mg Tablets, Aspen Pharmacare Australia Pty Ltd, Australia)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
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No Registry
INA-OZQWN67
Tanggal Input Registry : 19-12-2023

19-12-2023
Bioavailability of methyldopa 250 mg tablets, compared to that of Aldomet® 250 mg Tablets, following a single oral dose (1 × 250 mg tablet) in healthy adult subjects when administered under fasting conditions.
 
Bioequivalence study of methyldopa 250 mg tablets (Dopamet) produced by PT Actavis Indonesia in comparison with the comparator product (Aldomet® 250 mg Tablets, Aspen Pharmacare Australia Pty Ltd, Australia)
Bioequivalence study of methyldopa 250 mg tablets (Dopamet) produced by PT Actavis Indonesia in comparison with the comparator product (Aldomet® 250 mg Tablets, Aspen Pharmacare Australia Pty Ltd, Australia)
Observational
29080
 

Inclusion Criteria:

1. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 2. Healthy male and female aged between 18 to 55 years, inclusive, at the time of first signing of the informed consent. 3. Completed the screening process within 21 days prior to Period I dosing. 4. Body mass index (BMI) between 18.0 kg/m2 to 25.0 kg/m2, inclusive. 5. Judged by an investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments must be within the following ranges: - Systolic blood pressure : 110–129 mmHg - Diastolic blood pressure : 70–84 mmHg - Pulse rate : 60–90 bpm 6. Normal result of 12-lead electrocardiogram (ECG) and clinical laboratory assessments. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the investigator(s) and judged to be not clinically significant for study participation. 7. Negative urine screen for drugs of abuse (benzodiazepines, cannabinoids, amphetamines, cocaine, barbiturates and opioids) and alcohol urine test at screening and check-in for each study period. 8. For female volunteers, one of the following must apply: o Females of childbearing potential must practice one of the following acceptable methods of birth control as judged by the investigator(s), e.g. o Abstinent for 14 days prior to the first dose and until end of study o IUD in place for at least 3 months - If the IUD was inserted less than 3 months prior to Period I dosing or proper documentation of the confirmation test is not provided, the volunteer must agree to use an additional non-hormonal medically acceptable method of birth control o Use of barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and until end of study. o Use of hormonal contraceptives for at least 3 months prior to the first dose and until end of study. o Naturally postmenopausal (no menses) for at least 1 year o Surgically postmenopausal (bilateral oophorectomy or hysterectomy) or surgically sterile (bilateral tubal ligation) for at least 6 months - Surgically sterile or surgically postmenopausal must provide documentation of the bilateral tubal ligation, bilateral oophorectomy, or hysterectomy prior to Period I dosing or the volunteer must agree to use a medically acceptable non-hormonal method of birth control. 9. For male volunteers, one of the following must apply in order to avoid impregnating a female partner, from the first study dose until end of study: o Abstinent o Use of barrier method with spermicide. o Documented vasectomy or congenitally sterile 10. Study allows enrollment of light smokers: Reports smoking of less than 10 cigarettes/day, use of less than 4 packets/day of tobacco products or use of nicotine products (patches, gums, etc.) corresponding to less than 10 cigarettes/day. 11. Subject who agrees to avoid donating blood (1 unit or 350 mL) other than blood for study purposes and donating plasma (e.g. plasmapheresis) throughout the study and until 30 days after completing the study.

Exclusion Criteria:

Any of the following criteria excluded the subject from the study: 1. Reports receiving any investigational drug within 30 days prior to Period I dosing. 2. Participation in another clinical trial simultaneously. 3. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the investigator(s). 4. Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the investigator(s). 5. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study. 6. Demonstrates a positive pregnancy test. 7. Demonstrates a positive screening for hepatitis B surface antigen, hepatitis C antibody or HIV antibody. 8. Reports a history of drug or alcohol addiction or abuse within the past 1 year. a. Alcohol abuse defined as consumption of ≥7 units/week for females or ≥14 units/week for males b. One unit of alcohol equals 360 mL of beer; 150 mL of wine; or 45 mL of 40 % alcohol 9. Demonstrates a positive urine screening for drug abuse or a positive alcohol urine test. 10. Reports a clinically significant illness during the 30 days prior to Period I dosing (as determined by the investigator(s)). 11. Reports a history of allergic response(s) to the methyldopa or related drugs. 12. Reports a history of clinically significant allergies including food or drug allergies. 13. Reports donating blood (1 unit or 350 mL) or plasma (e.g. plasmapheresis) or significant blood loss within 90 days prior to Period I dosing. 14. Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture). 15. Reports difficulty fasting or consuming standardized meals. 16. Difficulty in swallowing solids like tablets or capsules. 17. Use of any prescription drug therapy or over-the-counter (OTC) drugs 21 days prior to receiving the first dose of study medication or repeated use of drugs within last 21 days. 18. GGT values ≥2 × ULN. 19. Have had a tattoo or body piercing within 90 days prior to the first dose. 20. Presence of significant infection within 1 week prior to screening and check-in. 21. Have live virus vaccinations (exceptional for inactivated seasonal flu) within 90 days prior to the dosing date.
 
KET-419/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
BE. 767/EQL/2022 Ver 2.0 (09 May 2023)
Yetty Afnita