Implant 1 Batang Etonogestrel

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT EQUILAB INTERNATIONAL
No Registry
INA-TPW9FSF
Tanggal Input Registry : 07-03-2022

19-10-2020
To find out whether the bioavailability of PT Harsen‟s formulation of etonogestrel 68 mg implant is equivalent to that of the comparator drug (Implanon NXT®, N.V. Organon, Oss, The Netherlands, registered by PT Merck Sharp Dohme Pharma Tbk, Indonesia)
To evaluate the efficacy of PT Harsen‟s formulation of etonogestrel 68 mg implant compared to that of the comparator drug (Implanon NXT®, N.V. Organon, Oss, The Netherlands, registered by PT Merck Sharp Dohme Pharma Tbk, Indonesia)
 
Implant 1 Batang Etonogestrel
PHARMACOKINETIC EQUIVALENCE AND EFFICACY ASSESSMENT OF ETONOGESTREL 68 MG IMPLANT PRODUCED BY PT HARSEN IN COMPARISON WITH THE COMPARATOR DRUG (IMPLANON NXT® , N.V. ORGANON, OSS, THE NETHERLANDS, REGISTERED BY PT MERCK SHARP DOHME PHARMA TBK, INDONESIA)
Observasional
Kesulitan dalam pencarian subjek yang bebas hormonal selama 3 bulan.
10800
 

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 female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation. 3. Aged 18-42 years inclusive. 4. Body mass index within 18.5 to 30 kg/m2 . 5. Non-smokers. 6. Vital signs (after 10 minutes rest) must be within the following ranges: Systolic blood pressure : 100 – 129 mmHg Diastolic blood pressure : 60 – 80 mmHg Pulse rate : 60 – 90 bpm 7. Had regular menstrual cycles of a usual length of 24–35 days. 8. Sexually active. 9. Had at least one biological child. 10.Not planning for pregnancy throughout the study (around 3 years). 11.Subject’s partner was willing to use condom as a backup method of birth control when the subject has sexual intercourse within 14 days before implant insertion and 7 days after implant insertion.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to etonogestrel or allied drugs or any of the component of implant. 2. History of breast or cervical cancer. 3. Undiagnosed vaginal bleeding. 4. Women using any form of hormonal contraceptive medications, including prolonged release medication (last injection within 6 months of this study’s first dosing day). 5. History of thrombosis or thromboembolic disorders. 6. Pregnant or lactating female (urinary pregnancy test will be applied at screening and before drug administration). 7. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 8. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. F. 246/EQL Final version 12.08.2021 Page 16 of 82 9. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 10.Clinically significant hematology abnormalities. 11.Clinically significant electrocardiogram (ECG) abnormalities. 12.Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug. 13.Past history of anaphylaxis or angioedema. 14.History of drug or alcohol abuse within 12 months prior to screening for this study. 15.Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day. 16.History of any bleeding or coagulative disorders. 17.Presence of difficulty in accessibility of veins in left or right arm. 18.A donation or significant blood loss within 90 days before this study’s first dosing day. 19.Intake of any prescription drug (especially etonogestrel), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
KET- 543/UN2.F1/ETIK/PPM.00.02/2020
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RG.01.02.321.10.20.00101/UB
BE. 608/EQL/2020
Dwiayu Maylan