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Pulmonary Arterial HypertensionPhase 1NCT06180096

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

A Phase 1 study testing Riociguat film coated tablets and Adempas Filmtabletten in people with Pulmonary Arterial Hypertension, run by Humanis Saglık Anonim Sirketi at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Riociguat film coated tablets and Adempas Filmtabletten
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndia
Study dates
7 Mar 2023to 6 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Volunteers must fulfill all of the following inclusion criteria to be eligible for participation
  • 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
  • 18.45 rounds up to 18.5).
  • Able to communicate effectively with study personnel.
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  • 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:
  • A physical examination (clinical examination) with no clinically significant finding.
  • Results within normal limits or clinically non-significant for the following tests: Hematology, Biochemistry, Urinalysis, Immunological Tests Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.

Who cannot join

  • 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.
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  • 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.
  • Intolerance to venipuncture
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
  • Institutionalized volunteers.
  • Use of any prescribed medications [including PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil, nitrates or nitric oxide donors (such as amyl nitrite), soluble guanylate cyclase stimulators] within 14 days prior to the first dose of study medication.
  • Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
  • Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
  • Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs (including poppers), alcohol or other alcohol containing products within 120 hours prior to the first dose of study medication.
  • Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
  • Volunteer having serum creatinine higher than upper limit of normal range in screening.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Cliantha Research Limited

    Ahmedabad, Gujarat, 382210

Other trials in India

About this study

Official title: 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

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.

Being tested
Riociguat film coated tablets, Adempas Filmtabletten
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Riociguat film coated tabletsDrug

    1 tablet of 2.5 mg Riociguat

  • Adempas FilmtablettenDrug

    1 tablet of 2.5 mg Riociguat

Study groups in NCT06180096
Study groupRoleWhat they receive
Riociguat film coated tabletsExperimentalRiociguat 2.5 mg film coated tablets
Receives: Drug: Riociguat film coated tablets; Drug: Adempas Filmtabletten
Adempas FilmtablettenActive comparatorAdempas (Riociguat) 2.5 mg Filmtabletten
Receives: Drug: Riociguat film coated tablets; Drug: Adempas Filmtabletten

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 48 hours

  2. 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

    Measured: 48 hours

Secondary outcomes (2)

  1. AUC from time 0 to infinity (AUC0-inf)

    Descriptive statistics

    Measured: 48 hours

  2. Time to reach maximum concentration Cmax (Tmax)

    Descriptive statistics

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start7 Mar 2023
  3. Primary completion17 Mar 2023
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180096
Sponsor's protocol ID
C1B02230
Status last verified
May 2023
First submitted
12 Dec 2023
Last updated
28 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Riociguat film coated tablets and Adempas Filmtabletten in people with Pulmonary Arterial Hypertension, run by Humanis Saglık Anonim Sirketi at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration obtained (Cmax) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06180096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.

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