Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

NCT04982861 | Completed DMC

• 1 other identifier: 432/STD/PML/2018
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use

Keywords

bioequivalence study; cefixime trihydrate; dry syrup; Indonesia

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Ratio

  The ratio between test drug and reference drug

  32 hours

• 90% confidence intervals

  The two products are considered bioequivalent when the 90% confidence intervals of the cefixime trihydrate geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax.

  32 hours

Secondary Outcomes (2)

• Pharmacokinetics parameter

  32 hours

• Pharmacokinetics parameter

  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

Study Arms (2)

Cefixime trihydrate 100 mg/5 mL dry syrup

EXPERIMENTAL

Cefixime trihydrate 100 mg/5 mL dry syrup was dissolved by 20 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water.

Drug: Cefixime Trihydrate 100 mg/5 mL Dry Syrup

Suprax® 100 mg/5 mL dry syrup

ACTIVE COMPARATOR

Suprax® 100 mg/5 mL dry syrup was dissolved by 33 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water.

Drug: Suprax 100 MG in 5 mL Oral Suspension

Interventions

Cefixime Trihydrate 100 mg/5 mL Dry Syrup DRUG

Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water

Cefixime trihydrate 100 mg/5 mL dry syrup

Suprax 100 MG in 5 mL Oral Suspension DRUG

Participants received a single dose of 5 mL of Suprax with 240 mL of water

Also known as: Cefixime Trihydrate 100 mg/5 mL Dry Syrup

Suprax® 100 mg/5 mL dry syrup

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• those who were pregnant and/or nursing women.
• 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
• 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.
• those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
• 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.
• those who had participated in any clinical study within 3 months prior to the study (\< 90 days).
• those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
• those who smoked more than 10 cigarettes a day.
• those who had a history of traveling to another city within the last 14 days
• those with a history of direct contact with a COVID-19 positive person in the subject neighborhood
• 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
• those who were positive to COVID-19
• those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
• those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
• those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, poor venous access.

Sponsors & Collaborators

• PT Bernofarm: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta, DKI Jakarta, 10520, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 16240707 BACKGROUND

• Kees F, Naber KG, Sigl G, Ungethum W, Grobecker H. Relative bioavailability of three cefixime formulations. Arzneimittelforschung. 1990 Mar;40(3):293-7.

  PMID: 2346538 BACKGROUND

• 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.

  PMID: 20070293 BACKGROUND

Related Links

• Clinical Pharmacology and Biopharmaceutic Review
• Guideline For Good Clinical Practice

MeSH Terms

Interventions

Cefixime; Suspensions

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• I Gusti Putu Bagus Diana Virgo

  PT Pharma Metric Labs, Indonesia

  STUDY DIRECTOR

• Arini Setiawati

  PT Pharma Metric Labs, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: June 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 25, 2020
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

ID (1)