PROTOKOL STUDI BIOEKIVALENSI

TABLET SAXAGLIPTIN/METFORMIN IMMEDIATE

RELEASE (IR) FIXED-DOSE COMBINATION (FDC) DAN
TABLET TUNGGAL SAXAGLIPTIN DAN METFORMIN
IR PADA SUKARELAWAN DEWASA SEHAT
 TUGAS FARMAKOKINETIK
MAGISTER FARMASI KLINIS UBAYA
ANGKATAN 28

Disusun oleh :
Agnes Christina Ay 114119005
Anna Ulfa Yana 114119006
Nuke Saswita 114119007
 Pokok Bahasan
Protokol Studi Bioekivalensi

Saxagliptin / Metformin IR FDC dan Single Component

Dosis 2,5 mg / 500 mg & 2,5 mg / 1.000 mg

1. Pendahuluan
2. Tujuan
3. Metode Penelitian
3.1. Subjek
3.2. Desain Penelitian
3.3. Pengambilan Sampel Darah
3.4. Bioanalytical Methods
3.5. Parameter Farmakokinetik
4. Laporan Hasil Studi
5. Kesimpulan
KLASIFIKASI BCS
Contoh Obat Berdasarkan BCS
 PERATURAN KEPALA BPOM RI NOMOR HK.03.1.23.12.11.10217
TAHUN 2011 TENTANG OBAT WAJIB UJI EKIVALENSI
OBAT WAJIB UJI EKIVALENSI (Pasal 2)
1. Obat Copy wajib dilakukan Uji Ekivalensi.
2. Uji Ekivalensi terhadap Obat Copy sebagaimana dimaksud pada ayat (1) dilakukan dengan
pembanding Obat Komparator.
3. Uji Ekivalensi sebagaimana dimaksud pada ayat (2) terdiri atas:
a. Uji Bioekivalensi; atau
b. Uji Disolusi Terbanding.
4. Uji Bioekivalensi sebagaimana dimaksud pada ayat (3) huruf a, wajib dilakukan untuk Obat
Copy dengan kelas terapi sebagaimana tercantum dalam Lampiran yang merupakan bagian
tidak terpisahkan dari Peraturan ini.
5. Selain Obat Copy yang tercantum dalam Lampiran sebagaimana dimaksud pada ayat (4)
dengan kelas terapi yang sama wajib dilakukan Uji Disolusi Terbanding.
6. Terhadap Obat Copy pertama dapat dipersyaratkan untuk wajib dilakukan Uji Bioekivalensi
berdasarkan hasil pengkajian
 Krtiteria Uji Bioekivalensi Berdasarkan Pedoman Uji Bioekivalensi
BPOM RI tahun 2004

Produk Obat yang memerlukan uji ekivalensi in vivo

a. Produk obat oral lepas cepat yang bekerja sistemik, yang memenuhi satu atau lebih kriteria
berikut ini :
 Batas keamanan/indeks terapi yang sempit; kurva dosis-respons yang curam, misal: digoksin,
antiaritmia, antikoagulan, obat-obat sitostatik, litium, feniton, siklosporin, sulfonilurea,
teofilin;
 Obat-obat untuk kondisi yang serius yang memerlukan respon terapi yang pasti (critical use
drugs), misal: antituberkulosis, antiretroviral, antimalaria, antibakteri, antihipertensi,
antiangina, obat gagal jantung, antiepilepsi, antiasma.
 Terbukti ada masalah bioavailabilitas atau bioinekivalensi dengan obat yang bersangkutan
atau obat-obat dengan struktur kimia atau formulasi yang mirip (tidak berhubungan dengan
masalah disolusi, misal: absorpsi bervariasi atau tidak lengkap; eliminasi presistemik yang
tinggi; farmakokinetik nonlinear; sifat-sifat fisiokimia yang tidak menguntungkan (misal:
kelarutan rendah, permeabilitas rendah, tidak stabil, dsb.); eksipien dan proses
pembuatannya diketahui mempengaruhi bioekivalensi.
 2. TUJUAN STUDI BE
Tujuan Umum Tujuan Khusus

Untuk menjamin efikasi, Mengevaluasi 2 studi bioekivalensi

keamanan dan mutu produk obat
yang beredar.
dari tablet saxagliptin/metformin IR
FDC dibandingkan dengan kekuatan
yang sama terhadap masing-masing
komponen yaitu tablet saxagliptin
dan tablet metformin IR

Studi 1
Tujuan Menilai tablet
Saxagliptin/Metformin IR
FDC 2,5 mg / 500 mg

Studi 2
Menilai tablet
Saxagliptin/Metformin IR
FDC 2,5 mg / 1.000 mg
3.1. Subjek Penelitian
3.1.1. 1. Subjek sehat, tidak merokok (dalam 1 bulan terakhir) pria maupun
Kriteria Inklusi wanita, sebagaimana ditentukan melalui riwayat pengobatan, penilaian
fisik, 12-lead electrocardiogram (ECG) dan uji laboratorium klinis
sehingga layak untuk berpatisipasi dalam penelitian ini.

2. Pria berumur 19 – 45 tahun berbadan sehat

3. BMI 18 – 32 kg/m2

4. Wanita berpotensi hamil tidak diperkenankan untuk hamil,

disarankan menggunakan metode kontrasepsi, diperbolehkan untuk
berpatisipasi dalam penelitian ini.

5. Uji kehamilan dilakukan pada subjek wanita 24 jam sebelum

pemberian terapi obat, dan hasilnya harus negatif.

6. Subjek setuju untuk membatasi olahraga yang berat, contact sport,

dan berjemur di bawah matahari selama penelitian berlangsung
7. Subjek tidak diijinkan untuk mengkonsumsi minuman dan makanan
yang mengandung alcohol, anggur, atau kafein selama 3 hari sebelum
pemberian dosis pertama dan selama penelitian berlangsung
3.1. Subjek Penelitian
3.1.1. 1. Subjek yang memiliki penyakit kronis atau akut
Kriteria Eksklusi
2. Subjek yang memiliki riwayat penyakit gastrointestinal atau baru terdeteksi

3. Subjek yang baru menjalani pembedahan gastrointestinal dalam 3 minggu

terakhir, dapat berdampak pada absorpsi obat
4. Subjek yang dalam 4 minggu terakhir menjalani major surgery

5. Subjek yang memiliki riwayat alergi atau intoleransi terhadap inhibitor

DPP-4 atau metformin atau obat lain yang sejenis
6. Subjek yang memiliki riwayat alergi yang signifikan terhadap beberapa
obat

7. Subjek yang sebelumnya pernah terpapar dengan saxagliptin dan

metformin selama 3 bulan atau subjek yang terlibat dalam studi investigasi
obat atau placebo selama 4 minggu

8. Subjek yang menggunakan obat ethical dan obat OTC untuk mengontrol
asam lambung dalam 4 minggu terakhir, ataupun obat OTC lainnya serta obat
herbal selama 2 minggu terakhir
 3.2. Desain Penelitian
DESAIN
Desain cross over, subjek sehat, pada
kondisi fed dan fasted, selama 4 periode,
acak (randomize), open label dan wash
out period satu minggu.
SCREENING
Subjek menjalani skrining untuk menentukan
kelayakan berpartisipasi dalam penelitian
dalam waktu 21 hari sebelum penelitian
dimulai.
PROTOKOL
Protokol dari kedua penelitian telah disetujui oleh
Komite Etik (MDS Pharma Services (US) Inc.
Instutional Review Board, Lincoln, NE, USA) dan
penelitian ini dijalankan berdasarkan pedoman yang
disepakati oleh Declaration of Helsinki. Setiap subjek
disediakan inform consent sebelum berpastisipasi
dalam penelitian ini.
PERAWATAN
Subjek yang dinyatakan layak, dirawat di
fasilitas klinis sehari sebelum pemberian
treatment (masing-masing dari 4 periode)
dan tetap di fasilitas klinis selama 4 hari.
 Skema Pemberian Treatment 4.
Setiap subjek menerima
treatment 1 kali (1 treatment
setiap 1 periode) pada pagi hari
2. dihari ke 1 berdasarkan hasil
Pemberian obat pada randomisasi dan setidaknya
kelompok fasted menjalani 7 hari (168 jam)
dilakukan pada pagi washout sebelum menerima
hari setelah setidaknya treatment berikutnya yang sudah
10 jam puasa pada di jadwalkan. 6.
malam sebelumnya. Subjek dipulangkan dari
fasilitas klinis pada hari ke
4 setelah pengambilan
sampel darah
5. farmakokinetik dan
3. Setelah setidaknya 7 evaluasi keamanan selesai.
Pemberian obat pada kelompok hari washout (4 hari
1. fed diberikan pada 5 menit antara periode), subjek
setelah menyelesaikan sarapan kembali ke fasilitas
Pada hari pertama periode 1, klinis dan menerima
standar (mengandung 336 kcal
total 24 subjek yang memenuhi treatment selanjutnya
dengan komposisi: 37
kriteria inklusi dan tidak secara bergantian.
kcalprotein (11%), 253 kcal
memenuhi kriteria eksklusi
karbohidrat (75%), 46 kcal
menerima treatment
lemak (14%) pada pagi hari).
3.2. Desain Penelitian
 Perbedaan Studi 1 dan 2

Studi 1 Studi 2
Uji Tablet Tablet
Saxagliptin/Metformin Saxagliptin/Metformin
IR FDC 2,5 mg / 500 IR FDC 2,5 mg / 1.000
mg mg

Pembanding Tablet Saxagliptin 2,5

Tablet Saxagliptin 2,5
mg plus ablet
mg plus tablet
Metformin 1.000 mg
Metformin 500 mg IR
IR
 3.3. Pengambilan Sampel Darah

1. 2.
Sampel darah dikumpulkan sebelum Whole blood diambil sebanyak 3.
pemberian treatment dan pada 15, 30 3 ml ke dalam tube yang Disentrifus pada 1,000xg
dan 45 menit dan 1, 1,5, 2, 3, 4, 6, 8, mengandung dipotassium selama 15 menit untuk
12, 18 dan 24 jam setelah treatment ethylediaminetetraacetic acid memisahkan plasma
(untuk metformin terdapat (K2EDTA)
penambahan pengambilan sampel
darah pada 36 dan 48 jam).

5.
Pengambilan sampel darah untuk
menentukan konsentrasi plasma dari
saxagliptin, 5 -hydroxy-saxagliptin
(metabolit aktif terbesar dari
saxagliptin yang menghambat aktivitas
plasma DPP-4), dan metformin
4.
Setelah sentrifugasi, plasma
sampel dipindahkan ke
tabung polypropylene ditutup
dan disimpan dibawah -200C
 Tablet
Saxagliptin/Metformin
IR FDC 2,5 mg / 500 mg
Dan
Tablet Saxagliptin 2,5
mg plus tablet
Metformin 500 mg IR

Tablet
Saxagliptin/Metformin
IR FDC 2,5 mg / 1.000
mg
Dan
Tablet Saxagliptin 2,5
mg plus tablet
Metformin 1.000 mg IR
 3.4. Bioanalytical Methods
Saxagliptin dan
5 -hydroxy-Saxagliptin
Sampel plasma dianalisa di
Tandem Labs, Inc. (West Trenton,
NJ, USA) menggunakan HPLC –
MS/MS
Batas bawah kuantifikasi (LLOQ)
dalam plasma masing-masing 0,1
dan 0,2 ng/mL.
Kisaran kalibrasi linear 0,1 – 50
ng/mL dan 0,2 – 100 ng/mL.
Koefisien variasi (CV) within and
between-run < 9,2%.
Metformin
Sampel plasma dianalisa di PPD
Bioanalytical Laboratory, Inc.
(Richmond, VA, USA) menggunakan
HPLC – MS/MS.
Batas bawah kuantifikasi (LLOQ)
dalam plasma 2 ng/mL.
Kisaran kalibrasi linear 2 – 1000
ng/mL.
Koefisien variasi (CV) within and
between-run < 5,9%.
3.5. Parameter Farmakokinetik
Parameter farmakokinetik subjek individu dihasilkan
dengan metode non-kompartemen standar dan
1 divalidasi menggunakan program farmakokinetik
(Kinetica version 4.4.1 Thermo Electron
Coorporation, Philadelphia, PA, USA).

Parameter farmakokinetik dosis tunggal untuk

saxagliptin dan metformin digunakan untuk
2 menentukan bioekivalensi antara FDC dan komponen
masing-masing yaitu Cmax,
AUC0-t, dan AUC∞.

Parameter ini juga digunakan untuk

3 mengkalkulasi 5 -hydroxy-saxagliptin tetapi
bukan untuk analisa bioekivalensi.

Parameter berikut dihitung untuk semua analit

4 yaitu waktu untuk mencapai Cmax (tmax) dan
t1/2..
 KESIMPULAN

 Dapat disimpulkan bioekivalensi jika CI 90%

untuk rasio uji terhadap pembanding dari mean
geometric sepenuhnya terdapat dalam rentang 0,800
– 1,250 untuk Cmax dan AUC∞ dari saxagliptin dan
metformin.

 Hasil penelitian tersebut menunjukkan bahwa

saxagliptin FDCs metformin IR bersifat bioekivalen
dengan individu-nya yaitu komponen IR saxagliptin
dan metformin diberikan bersama-sama pada subyek
yang berpusa maupun yang tidak berpuasa.
Thank You
 3.6. Analisa Statistik
1. Statistic deskriptif
Parameter farmakokinetik baik
pembanding dan treatment
dirangkum menggunakan statistic
deskriptif (jumlah subjek, mean, SD,
CV).
3. Linear mixed model
Untuk menilai efek dari formulasi
(tablet FDC vs pemberian tablet
terpisah saxagliptin dan metformin
IR) terhadap bioavaibilitas dari
saxagliptin dan metformin, model
campuran linear dengan fixed factor
periode dan treatment pada setiap
subjek sebagai pengukuran berulang
ditunjukkan dengan log (Cmax), log
(AUClast), dan AUC∞ dari saxagliptin
dan metformin, masing-masing,
untuk menilai perbedaan antara
produk uji dan pembanding pada
studi 1 dan studi, kondisi fasted dan
2. Statistic geometric
Mean geometric dimasukkan untuk
2
Cmax dan AUC
1
4. Confidence interval 90%
4 Estimasi point dan confidence
3 interval 90% (CIs) dihitung untuk
rasio produk uji terhadap produk
pembanding dari mean geometric
untuk Cmax, AUClast), dan AUC∞ pada
pengukuran skala asli.
5. Kesimpulan BE
Disimpulkan bioekivalensi jika CI
90% untuk rasio uji terhadap 5
pembanding dari mean geometric
sepenuhnya terdapat dalam rentang
0,800 – 1,250 untuk Cmax dan AUC∞
dari saxagliptin dan metformin.
3.7. Laporan Keamanan dan Tolerabilitas

Adverse events (AEs) secara tidak

disengaja dilaporkan atau terjadi
selama sesi pertanyaan terbuka,
pemeriksaan atau evaluasi pada
setiap subjek.

Pencegahan bias Data Subjek

Untuk mencegah Data dari semua peserta
pelaporan bias, subjek penellitian dimasukkan dalam
tidak ditanyai mengenai penilaian keamanan dan
kejadian spesifik satu tolerabilitas Penilaian keamanan
atau lebih AE. dan tolerabilitas termasuk AEs,
hasil laboratorium klinis,
pengukuran tanda-tanda vital,
hasil 12-lead ECG dan temuan
pemeriksaan fisik.
 4. Laporan
Hasil Studi
Total Subjek Discontinued
Masing-masing studi - 2 subjek tidak melanjutkan
(studi 1 dan studi 2) studi karena AE selama
memiliki pastisipan 24 washout period setelah
subjek. pemberian treatment pertama
di antara periode 1 dan 2 (1
subjek nyeri telinga, 1 subjek
sakit tenggorokan)
- 1 subjek gagal check in pada
periode 2 dan tidak
melanjutkan studi setelah
menerima 1 treatment
- 3 subjek tidak melanjutkan
Studi 1 Studi 2
studi setelah treatment kedua
Semua dari 24 subjek Hanya 18 subjek yang dengan berbagai alasan (1
tersebut menyelesaikan menyelesaikan sudi 2 tidak lagi memenuhi kriteria
studi 1 (saxagliptin/metformin karena hasil uji lab
(saxagliptin/metformin 2,5 mg / 500 mg). menunjukan peningkatan, 1
2,5 mg / 500 mg FDC). alasan pribadi, 1 gagal check
in pada periode 3)
 KESIMPULAN

 Disimpulkan bioekivalensi jika CI 90% untuk rasio

uji terhadap pembanding dari mean geometric
sepenuhnya terdapat dalam rentang 0,800 – 1,250
untuk Cmax dan AUC∞ dari saxagliptin dan
metformin.

 Hasil penelitian tersebut menunjukkan bahwa

saxagliptin FDCs metformin IR bersifat bioekivalen
dengan individu-nya yaitu komponen IR saxagliptin
dan metformin diberikan bersama-sama pada subyek
yang berpusa maupun yang tidak berpuasa.
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