ClinicalTrials.gg
Sign In
CompletedNCT03173742Updated Jun 2, 2017

Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil)

A Phase 1 interventional study of T1, T2, T3 and T1,T3,T2 in Helminthiasis, sponsored by Insud Pharma. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-02.

Sponsored by Insud Pharma · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2016, registered May 2017).
Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose, three-period crossover trial in healthy volunteers.

02

Conditions studied

  • Helminthiasis

Browse trials for

03

In context

Helminthiasis

65 studies on the registry are indexed under Helminthiasis; 3 are open to participants now.

This study's enrollment of 54 is below the median of 317 across 41 interventional studies indexed under Helminthiasis.

Browse Helminthiasis studies →

Lead sponsor

Insud Pharma is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Caucasian subjects of either gender (male or female) with an age between 18 and 45 years (both inclusive).
  2. Medical history and physical examination with no relevant abnormal findings.
  3. No evidence of significant disease (organic or psychiatric) based on medical history, physical examination and complementary tests.
  4. Laboratory tests (complete hematology, clinical chemistry and urinalysis).
  5. Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and electrocardiogram (ECG) record within normal range at screening.
  6. Participating female volunteers must use a reliable contraception method not containing hormones. List of accepted contraception method includes barrier methods (i.e. female/male condoms, diaphragms, spermicides), voluntary sterilization (female tubal occlusion) or non-medicated intrauterine devices (IUD) (i.e. inert or copper-releasing). Abstention is not considered a reliable contraception method.
  7. For female volunteers only: they must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant during one month following the last study drug administration.
  8. Voluntary participation in the study, with written informed consent from the volunteer.
  9. The subject agrees to abstain from beverages or food containing methylxanthines (coffee, tea, cola, energy drinks, chocolate etc.), St John's Wort, vitamins, herbal remedies and chewing-gum for 48 hours prior to study drug administration and during each study period.
  10. The subject agrees to abstain from beverages or food containing grapefruit for 14 days prior to the first study drug administration and during the study (until last sample from the last period).

Exclusion criteria

Exclusion Criteria:

  1. Background of allergy, idiosyncrasy or hypersensitivity to the study drugs or its excipients.
  2. Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
  3. Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol > 40 gr/day for men or > 24 gr/day for women.
  4. Use of any medication within 15 days prior to taking the study treatment, including over-the-counter medications and medicinal plants (except for the use of paracetamol in short-term symptomatic treatments).
  5. Positive serology for hepatitis B, C or HIV.
  6. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
  7. Smokers or ex-smokers that gave up smoking less than 1 year prior to the study (day 1 of period I)
  8. Pregnancy or lactation status for female subjects.
  9. Participation in another clinical trial during the 3 months before starting the current trial.
  10. Donate blood in the 8 weeks prior to starting the study.
  11. Undergone major surgery during the previous 6 months.
  12. Clinically significant abnormal ECG with clinical significance in accordance with the CIM's clinical criterion
  13. Restrictive vegetarian diet
  14. Positive results to the breath alcohol test at screening or at Day -1
  15. Positive results to the drug abuse checks (urine test for: amphetamines, cannabinoids, opiates, benzodiazepines and cocaine) at screening or at admission on Day -1
  16. Epidemiological risk of being infected by Loa loa or other filariases, defined as those who have lived or have travelled to any of the following countries: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    T1, T2, T3

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T1, T2, T3

  • Experimental
    T1, T3, T2

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T1,T3,T2

  • Experimental
    T2,T1,T3

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T2,T1,T3

  • Experimental
    T2,T3,T1

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T2,T3,T1

  • Experimental
    T3,T1,T2

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T3,T1,T2

  • Experimental
    T3,T2,T1

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Drug: T3,T2,T1

Interventions

  • DrugT1, T2, T3

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 1-2-3

  • DrugT1,T3,T2

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 1-3-2

  • DrugT2,T1,T3

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 2-1-3

  • DrugT2,T3,T1

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 2-3-1

  • DrugT3,T1,T2

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 3-1-2

  • DrugT3,T2,T1

    T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)

    Also known as: Treatment 3-2-1

06

What researchers measure

Primary outcomes

  1. Primary endpoint evaluated will be the PK parameters that define bioavailability in extent Ln [AUC0t]

    For group 3

    Time frame: up to day 7

  2. Primary endpoint evaluated will be the PK parameters that define bioavailability in extent in rate: Ln [Cmax] for each treatment in healthy volunteers with high weight (Group 3), calculated by means of a non-compartmental analysis.

    For group 3

    Time frame: up to day 7

Secondary outcomes

  1. Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent Ln [AUC0t]

    for group 1 and 2

    Time frame: up to day 7

  2. Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent in rate: Ln [Cmax]

    for group 1 and 2

    Time frame: up to day 7

  3. AUC0t (for non-compartmental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  4. AUC0∞ (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  5. %AUC extra (residual area) (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  6. tmax (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  7. tlag (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  8. Cl/F (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  9. V/F (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  10. t1/2 (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  11. Ke (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  12. MRT (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  13. Cmax (for non-compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  14. tlag (for compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  15. ka (for compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: D7

  16. Cl/F(for compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  17. V/F (for compartimental analysis)

    PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis

    Time frame: up to day 7

  18. vital signs

    To asses safety and tolerability of the treatments

    Time frame: up to week 6

  19. laboratory analysis

    To asses safety and tolerability of the treatments

    Time frame: up to week 6

  20. Incidence of adverse events.

    To asses safety and tolerability of the treatments

    Time frame: up to week 6

  21. ECG

    To asses safety and tolerability of the treatments

    Time frame: up to week 6

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Munoz J, Ballester MR, Antonijoan RM, Gich I, Rodriguez M, Colli E, Gold S, Krolewiecki AJ. Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006020. doi: 10.1371/journal.pntd.0006020. eCollection 2018 Jan. PubMed 29346388 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03173742
Lead sponsor
Insud Pharma
Responsible party
Sponsor
First posted
Jun 2, 2017
Start date
Mar 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Jun 2, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Triiodothyronine

Other studies in this condition

Helminthiasis →

Other studies from this sponsor

Insud Pharma

Start the discussion