Home » Trials » SLCTR/2017/035


A Bioequivalence study on the innovator and a generic amoxicillin trihydrate 500mg capsules in healthy volunteers -

SLCTR Registration Number

SLCTR/2017/035


Date of Registration

09 Oct 2017

The date of last modification

Oct 09, 2017



Application Summary


Scientific Title of Trial

A Bioequivalence study on the innovator and a generic amoxicillin trihydrate 500mg capsules in healthy volunteers


Public Title of Trial

A bioequivalence study on a generic product of amoxicillin


Disease of Health Condition(s) Studied

Comparative pharmacokinetic study on an antibiotic on healthy human volunteers


Scientific Acronym

None


Public Acronym

None


Brief title

A bioequivalence study on a generic product of amoxicillin


Universal Trail Number

U1111-1201-9050


Any other number(s) assigned to the trial and issuing authority

EC-15-160


Trial Details


What is the research question being addressed?

Does the test product of amoxicillin 500mg capsules show similar pharmacokinetic parameters as compared to that of the innovator product of amoxicillin 500mg capsules?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Crossover


Purpose

Other


Intervention(s) planned

Study setting: a private hospital in Colombo, Sri Lanka.

Method of randomization: Simple randomization

Study design: open label, single dose, under fasted and fed conditions comparing the generic (test) product with the innovator, randomized into four treatment periods, as a cross-over study after a wash out period of 7 days

Interventions Innovator product of amoxicillin 500mg capsules (Amoxil 500mg manufactured by GlaxoSmithkline Ltd) as the comparator product and a locally manufactured amoxicillin 500 mg capsule (Axcil 500mg by AstronPvt Ltd) as the test product

Dose: one test product of 500mg amoxicillin capsule and one innovator amoxicillin 500 mg capsule.

Route: Oral

Duration and frequency: Single dose only

Treatment periods Fasted: A single dose of generic or the test product will be administered after 12 hours of overnight fasting.

Subjects to fast overnight (from 8 p.m. only water is allowed). Subjects need to abstain from water for at least one hour before dose. (from 7.00 a.m) Pre dose blood sample will be collected before 8.00 a.m. A single dose of 500 mg amoxicillin trihydrate capsule, either comparator (innovator) or the test formulation will be administered with 240 ml drinking water by 8.00 a.m. Subjects will abstain from drinking water for another one hour after dosing. However, drinking water will be allowed ad libitum after the first hour samples are collected.

Fed: A single dose of the test product will be administered ½ hour after a high calorie high fat meal.

Subjects to fast overnight (from 8 p.m. only water is allowed). Subjects need to abstain from water for at least one hour before dose. (from 7.00 a.m) At 7.30 a.m. standardized breakfast will be served. Pre dose blood sample will be collected before 8.00 a.m. A single dose of 500 mg amoxicillin trihydrate capsule, either comparator (innovator) or the test formulation will be administered with 240 ml drinking water by 8.00 a.m (half an hour after the breakfast).

Subjects will abstain from drinking water for another one hour after dosing. However, drinking water will be allowed ad libitum after the first hour samples are

In period 2 of the study, subjects will cross over to alternative treatment schedule and the same study procedures will be performed. There will be wash out period of 7 days between each intervention.


Inclusion criteria

  1. Healthy volunteer males and females of 18-55 years of age.
  2. Weight within the normal range according to accepted normal values for the Body Mass Index between 18-25 kg/m2
  3. Stable health screening for medical and medical histories, physical examination, vital signs, ECG, Renal Function Test, Liver Function Test, Blood Glucose, Complete Blood Count and urine pregnancy test for females.
  4. Preferably be non-smokers and without a history of alcohol or drug abuse.

Exclusion criteria

  1. History of allergic reactions to the selected drug and or its constituents
  2. History or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug
  3. Regular alcohol consumption (more than 1 time/week) or drug abuse
  4. Smokers or ex-smoker less than 30 days
  5. Use of any drugs within 14 days prior to administration of the first study drug and willing to take them throughout the study period
  6. Use of food supplements taken as capsules or tablets or neutraceuticals, vitamins, minerals, herbal remedies, and/or contraceptives hormonal within 14 days before first study drug administration and willing to taking them throughout the study period
  7. History of gastrointestinal disease
  8. Already participated in another clinical study within last 30 days
  9. Pregnant (positive pregnancy test) or breast feeding
  10. Blood donation within last 90 days


Primary outcome(s)

  1. Cmax: Maximum drug Concentration in plasma

    1. T max: Time to reach maximum drug concentration in plasma
  2. AUC: Area Under the Concentration/Time Curve


Primary outcome(s) - Time of assessment(s)

Serial blood sampling at before dosing (0 hr) and 0.5, 0.75, 1.0, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 5.0, 7.0, 9.0, and 12.0 hours after dosing


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

12 (up to 24 as determined based on the variance estimates and point estimate calculated from the stage 1 data)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-10-09


Anticipated end date

2017-11-30


Recruitment status

Pending


State of ethics review approval

Approved from Ethics Review Committee, Faculty of Medicine, University of Colombo on 17th December 2015 Ref. No. : Ec-15-160 Extension Date :17th December 2016


Funding source

University of Colombo research grant AP/03/2012/CG/12



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Professor Priyadarshani Galappatthy
Professor of Pharmacology
Department of Pharmacology, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0718655651
Fax: 0112697483
p.galappatthy@pharm.cmb.ac.lk

Contact Person for Public Queries

Ms. Dhanusha Thambavita
Lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0718731302
Fax: 0112697483
tmdhanusha@yahoo.com


Primary study sponsor/organization

University of Colombo

Cumaratunga Munidasa Mawatha Colombo 03, Sri Lanka
Tel: (+94) 112 581 835


http://www.cmb.ac.lk

Secondary study sponsor (If any)

None