Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets

NCT06180096 | Completed Phase 1

• 1 other identifier: C1B02230
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Single dose oral bioequivalence study of Riociguat 2.5 mg film coated tablets and 'Adempas' (Riociguat) 2.5 mg Filmtabletten (film coated tablets) in healthy adult male subjects under fasting conditions.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Maximum concentration obtained (Cmax)

  Two-sided 90% confidence interval for the test to reference ration of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax

  48 hours

• AUC from time 0 to last collection time t (AUC)

  Two-sided 90% confidence interval for the test to reference ration of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-t

  48 hours

Secondary Outcomes (2)

• AUC from time 0 to infinity (AUC0-inf)

  48 hours

• Time to reach maximum concentration Cmax (Tmax)

  48 hours

Study Arms (2)

Riociguat film coated tablets

EXPERIMENTAL

Riociguat 2.5 mg film coated tablets

Drug: Riociguat film coated tablets; Drug: Adempas Filmtabletten

Adempas Filmtabletten

ACTIVE COMPARATOR

Adempas (Riociguat) 2.5 mg Filmtabletten

Drug: Riociguat film coated tablets; Drug: Adempas Filmtabletten

Interventions

Riociguat film coated tablets DRUG

1 tablet of 2.5 mg Riociguat

Adempas Filmtabletten; Riociguat film coated tablets

Adempas Filmtabletten DRUG

1 tablet of 2.5 mg Riociguat

Adempas Filmtabletten; Riociguat film coated tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• in the study, unless otherwise specified. 1) Age: 18 to 45 years old, both inclusive. 2) Gender: Male
• BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one
• significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while
• rounds up to 18.5).
• Able to communicate effectively with study personnel.
• Willing to provide written informed consent to participate in the study.
• Non-smokers and non-tobacco users (i.e. having no past history of smoking and
• tobacco consuming for at least one year prior to study).
• Volunteer must have sitting systolic blood pressure at least 100 mmHg and sitting
• diastolic blood pressure at least 60 mmHg during screening.
• Volunteer must agree to either abstain from sexual intercourse or use an acceptable
• method of birth control from screening until 4 weeks after the last study procedure.
• All volunteers must be 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 study medication which will include:

You may not qualify if:

• Volunteers must not be enrolled in the study if they meet any one of the following criteria:
• History of allergic responses to Riociguat or other related drugs, or any of its formulation ingredients.
• Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording\].
• Any disease or condition like diabetes, psychosis or others, which might compromise 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 study medication.
• A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody.
• Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
• History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 382210, India

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

riociguat

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

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: December 12, 2023
• First Posted: December 22, 2023
• Study Start: March 7, 2023
• Primary Completion: March 17, 2023
• Study Completion: April 6, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)