Clinical trial NCT04982861: Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers
Official title: Bioequivalence Study of Cefixime Trihydrate 100 mg/5 mL DS in Indonesia Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: bioequivalence study
cefixime trihydrate
dry syrup
Indonesia
Lead sponsor: PT Bernofarm
Sponsor class: INDUSTRY
Collaborators: name: PT Pharma Metric Labs
First posted: 2021-07-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.
Primary purpose: BASIC_SCIENCE

Brief summary: This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.

Detailed description: Twenty two healty subjects were given a single dose of 100 mg/5 mL cefixime trihydrate dry syrup or or 100 mg/5 mL Suprax® dry syrup with 240 mL of water. Then the blood samples for cefixime trihydrate was drawn and analyzed using HPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects
2. Had read the subject information and signed informed consent documents
3. Age 18 - 55 years
4. Body mass index between 18-25 kg/m2
5. Had a normal electrocardiogram
6. Blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
7. Heart rate within normal range (60-100 bpm)
8. The absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

1. those who were pregnant and/or nursing women.
2. those who had a history of contraindication or hypersensitivity to cefixime, other antibiotics or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction
3. those who had a history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, and cardiovascular disease.
4. those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
5. those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day.
6. those who had participated in any clinical study within 3 months prior to the study (\< 90 days).
7. those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
8. those who smoked more than 10 cigarettes a day.
9. those who had a history of traveling to another city within the last 14 days
10. those with a history of direct contact with a COVID-19 positive person in the subject neighborhood
11. those with a history or presence of sore throat, fever (with temperature more than 37°C) or short of breath within the last 14 days
12. those who were positive to COVID-19
13. those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
14. those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
15. those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, poor venous access.

Primary outcomes:
measure: Geometric Mean Ratio
timeFrame: 32 hours
measure: 90% confidence intervals
timeFrame: 32 hours
Secondary outcomes:
measure: Pharmacokinetics parameter
timeFrame: 32 hours
measure: Pharmacokinetics parameter
timeFrame: pre-dose at (0 h) and post dose at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Pharma Metric Labs
state: DKI Jakarta
Study officials:
affiliation: PT Pharma Metric Labs, Indonesia
name: I Gusti Putu Bagus Diana Virgo
role: STUDY_DIRECTOR
affiliation: PT Pharma Metric Labs, Indonesia
name: Arini Setiawati
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asiri YA, Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Yamani MJ, Alsarra IA, Al-Balla SA. Comparative bioavailability study of cefixime (equivalent to 100 mg/5 ml) suspension (Winex vs Suprax) in healthy male volunteers. Int J Clin Pharmacol Ther. 2005 Oct;43(10):499-504. doi: 10.5414/cpp43499.
citation: Kees F, Naber KG, Sigl G, Ungethum W, Grobecker H. Relative bioavailability of three cefixime formulations. Arzneimittelforschung. 1990 Mar;40(3):293-7.
citation: Morais JA, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):221-5. doi: 10.1111/j.1742-7843.2009.00518.x. Epub 2010 Jan 7.