Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream

NCT06557603 | Completed Phase 1

• 1 other identifier: C1B01784
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (2)

• Maximum measured plasma concentration (Cmax)

  If the reference product intra-subject CV is less than or equal to 30% for Cmax, then the 90% confidence interval of the relative mean Cmax of the test to reference formulation for Ln-transformed data was to be within 80.00% to 125.00%.

  21 hours

• Area under the plasma concentration versus time curve from the time zero time point to the last quantifiable concentration (AUCt)

  The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%

  21 hours

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve from time zero to infinity (AUCi)

  21 hours

• Time of the maximum measured plasma concentration (Tmax)

  21 hours

Study Arms (2)

Ivermectin cream

EXPERIMENTAL

Ivermectin 1% cream

Drug: Ivermectin cream; Drug: Soolantra ® (Ivermectin) cream

Soolantra (Ivermectin) cream

ACTIVE COMPARATOR

Soolantra (Ivermectin) 10 mg/g cream

Drug: Ivermectin cream; Drug: Soolantra ® (Ivermectin) cream

Interventions

Ivermectin cream DRUG

\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

Ivermectin cream; Soolantra (Ivermectin) cream

Soolantra ® (Ivermectin) cream DRUG

\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

Ivermectin cream; Soolantra (Ivermectin) cream

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 36 Male + 08 Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 45 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first cream application day. They has used an acceptable form of contraception.
• B. For female of childbearing potential, acceptable forms of contraception included the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• C. Female was not considered of childbearing potential if one of the following was reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
• Volunteer having weight ≥ 50 Kg.
• The Volunteers were able to communicate effectively with study personnel.
• The Volunteers willing to provide written informed consent to participate in the study.
• All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of cream application which included:
• A physical examination (clinical examination) with no clinically significant finding.

You may not qualify if:

• Volunteers who met any one of the following criteria were not enrolled in the study.
• History of allergic responses to Ivermectin or other related drugs, or any of its formulation ingredients.
• Female subjects of childbearing potential had unprotected sexual intercourse with any non-sterile male partner (i.e. male who was not sterilized by vasectomy for at least 6 months) within 14 days prior to the first dose of cream application.
• Currently pregnant, lactating or breast-feeding (for female volunteers).
• Use of oral contraceptives within 30 days prior to the first dose of cream application (for female volunteers).
• Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• History or presence of bronchial asthma.
• Use of any hormone replacement therapy within 3 months prior to the first dose of cream application.
• A depot injection or implant of any drug within 3 months prior to the first dose of cream application.
• Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of cream application.
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• Smokers who smoked 10 or more cigarettes per day or 20 or more biddies per day or those who could not refrained from smoking during the study period.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (includes subtypes B \& C).

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Vadodara, Gujarat, 390012, India

Location

MeSH Terms

Conditions

Rosacea

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: March 6, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 22, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)