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Bioequivalence Study of Ivacaftor 150 mg Film‑Coated Tablets in Healthy Adults for Cystic Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at Cystic Fibrosis, a genetic condition that causes thick mucus in the lungs and digestive system. It compares two oral tablets that contain the medicine Ivacaftor. One tablet is marketed as Kalydeco, and the other is a generic version made by another company. The aim is to determine bioequivalence, meaning the two tablets work the same way in the body.

Healthy adult volunteers will take one tablet and, after a short break, will take the other tablet, with each taken as a single dose after a meal (fed condition). Blood samples will be collected to see how quickly and how much of the medicine reaches the bloodstream, allowing comparison of the two products. No other treatments are given and participants are monitored for safety throughout the short study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You arrive at the study site after you have been enrolled. study staff will check your health status, confirm that you meet the study criteria, and explain the procedures you will follow.

    You will be given a standard meal to ensure the study is conducted under fed condition, which means the medication must be taken after eating.

  2. Step 2

    First dose administration (period 1)

    After finishing the meal, you will take one tablet containing 150 mg of ivacaftor. the tablet may be either the test product (ivacaftor film‑coated tablets 150 mg from sun pharmaceutical) or the comparator product (kalydeco 150 mg film‑coated tablet).

    The tablet is taken orally once, and no additional doses are given during this period.

  3. Step 3

    Blood sample collection after first dose

    A series of blood samples will be drawn from you at several time points over the next hours to measure how much ivacaftor is in your bloodstream.

    These samples help determine the primary measurements of the study, such as the maximum concentration (cmax) and the overall exposure (auc0‑t).

  4. Step 4

    Washout period

    After the blood sampling is completed, you will have a break of several days to allow the drug to leave your body completely before the next dose.

    During this time you will not take any study medication.

  5. Step 5

    Second dose administration (period 2)

    You will again receive a standard meal, and then you will take the other tablet that you did not receive in period 1.

    The tablet also contains 150 mg of ivacaftor and is taken orally once.

  6. Step 6

    Blood sample collection after second dose

    As after the first dose, a series of blood samples will be collected at multiple time points to assess the drug levels from the second tablet.

    These measurements are used to compare the test product with the comparator product.

  7. Step 7

    Final follow‑up visit

    Once all blood samples have been taken, you will attend a final visit where study staff will review any remaining observations and complete the study documentation.

    No further study medication will be taken after this visit.

Who can join the trial?

6 criteria

  • Healthy male or female volunteer aged 18 to 45 years (you must be between 18 and 45 years old).
  • You must follow a non‑vegetarian diet (you eat meat, fish, eggs, or any animal protein).
  • Your Body mass index (BMI) must be between 18.5 and 29.0 kg/m². BMI is a simple calculation that compares your weight to your height.
  • You must sign a written informed consent, which is a document showing that you understand the study and agree to join.
  • All screening tests must be completed within 28 days before the first dose of the study medicine.
  • If you are female, you must be non‑pregnant and non‑lactating (not breastfeeding) and agree to use an effective birth control method during the study, such as condoms, diaphragm, a non‑hormonal intrauterine device, abstinence, be surgically sterile, or be post‑menopausal for at least 2 years.

Who cannot join the trial?

16 criteria

  • You must not have had an allergic reaction to ivacaftor or to any of its inactive ingredients (called excipients).
  • You must not have a habit of drinking more than 2 units of alcohol each day (for example, more than 500 mL of beer, 200 mL of wine, or 50 mL of spirits).
  • You must not have used any medicine or dietary supplement that speeds up (induces) the way the study drug is broken down in the body within the last 28 days, or any that slows down (inhibits) this process within the last 14 days.
  • You must not have taken part in another clinical trial with an experimental drug in the past 12 weeks.
  • You must not have donated blood or lost a large amount of blood (400 mL or more) in the past 12 weeks.
  • You must not have a positive urine test for illegal drugs when screened.
  • You must not have a positive urine or blood test for pregnancy when screened.
  • If you could become pregnant, you must not have had unprotected sex with a male partner who is not permanently sterile (has not had a vasectomy for at least 6 months) within the 14 days before taking the study drug.
  • You must not have a history of high or low blood pressure, or current blood pressure readings above 140/90 mmHg (high) or below 90/60 mmHg (low) while sitting.
  • You must not have serious stomach, liver, kidney, or other illnesses that could affect how the study drug is absorbed, moved, broken down, or removed from the body.
  • You must not test positive for HIV, hepatitis B or C, or syphilis infections.
  • You must not have important abnormal results in routine lab tests, as judged by the study doctor.
  • You must not have significant irregularities in a heart test called an ECG (electrocardiogram) that could affect safety.
  • You must not have serious heart, lung, nerve, reproductive, muscle‑bone, lymph, blood, diabetes, or immune‑system diseases, or any other condition that the doctor believes could put you at risk or affect the study results.
  • You must not have a history of any psychiatric (mental health) illness.
  • You must not be a regular smoker who smokes more than 5 cigarettes a day.
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Verified sites

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  • Verified

    Terapia S.A.

    RomaniaCluj Napoca, Romania

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Investigated drugs

  • Kalydeco

    is an oral, film‑coated tablet that contains the medicine ivacaftor. In this study it is used as the reference product, meaning the researchers already know how it works and how much of the drug gets into the body. The purpose of including Kalydeco is to compare a new tablet made by another company to see if it behaves the same way in healthy adults after a meal.

  • Ivacaftor film coated tablets

    (test product) are also oral tablets that contain ivacaftor, but they are manufactured by Sun Pharmaceutical Industries. In the trial this tablet is the test product, and the researchers give it to participants to find out whether it delivers the same amount of drug to the bloodstream as Kalydeco when taken with food. The study aims to show that the new tablet is bioequivalent, meaning it works in the same way as the approved medicine.

What is already known about the treatment

  • Kalydeco 150 mg film-coated tablets

    This medication is taken orally as a film‑coated tablet that is swallowed with water. It is an approved, prescription drug that is listed in medical literature as a treatment for cystic fibrosis in patients who have specific genetic mutations. The tablet helps the faulty protein in the lungs work more normally, allowing better movement of salt and water across cell surfaces. It belongs to the drug class known as CFTR potentiators, which improve the function of the cystic fibrosis transmembrane conductance regulator protein.

  • Ivacaftor film coated tablets 150 mg

    This product is also taken by mouth as a film‑coated tablet that is swallowed with water. It is a generic version of an approved medication and is being studied for use in cystic fibrosis patients with the same genetic mutations. Like the branded tablet, it works by helping the defective protein in the lungs function better, improving the flow of salt and water in the body’s cells. It is classified as a CFTR potentiator, a type of drug that enhances the activity of the cystic fibrosis transmembrane conductance regulator.

Investigated diseases

Cystic fibrosis - Cystic fibrosis is a genetic disorder that affects the lungs and digestive system. It is caused by mutations in the CFTR gene, leading to thick, sticky mucus. The mucus clogs airways, causing chronic cough and frequent lung infections. In the digestive tract, it blocks enzymes, making nutrient absorption difficult. Over time, lung damage can worsen and digestive problems may lead to growth issues.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508115-23-00Protocol codeIVACA-05-23Estimated enrolment52 patientsSponsorSun Pharmaceutical Industries Limited

sourced from the EU Clinical Trials Register and site verification

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