HealthyPhase 1NCT02516098

Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

A Phase 1 study testing hyoscine butylbromide in people with Healthy, run by Boehringer Ingelheim at 1 site in Canada.

Completed

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

Trial summary

Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: hyoscine butylbromide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteCanada
Study dates: Oct 2015to Dec 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy males and females, aged 18-50years, BMI 18,5-30

Who cannot join

History of hypersensitivity or allergy to IMP

Trial locations and contacts

1 site in 1 country.

Canada1 site

Boehringer Ingelheim Investigational Site
Bloemfontein

Other trials in Canada

About this study

Official title: A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions

Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.

Conditions: Healthy
Being tested: hyoscine butylbromide

What participants receive

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

hyoscine butylbromideDrug

Study groups in NCT02516098
Study group	Role	What they receive
Hyoscine butylbromide SCT	Active comparator	Not described Receives: Drug: hyoscine butylbromide
Hyoscine butylbromide	Experimental	Not described Receives: Drug: hyoscine butylbromide

What is being measured

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

Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
The maximum measured concentration of hyoscine butylbromide in plasma.
Measured: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).
Measured: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Secondary outcomes (2)

Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)
Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.
Measured: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Timeline

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

Oct 2015Dec 2015

First posted5 Aug 2015 (estimated)
Study startOct 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02516098
Sponsor's protocol ID: 202.850
Status last verified: Mar 2017
First submitted: 3 Aug 2015
Last updated: 5 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions
ClinicalTrials.gov ID: NCT02516098
Acronym / sponsor ID: 202.850
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 5 Aug 2015 (estimated)
Results: Posted 13 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Hyoscine butylbromide SCT	Active comparator	Drug: hyoscine butylbromide
Hyoscine butylbromide	Experimental	Drug: hyoscine butylbromide

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

healthy males and females, aged 18-50years, BMI 18,5-30

Key exclusion criteria (1 listed)

History of hypersensitivity or allergy to IMP

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hyoscine butylbromide	Drug	Hyoscine butylbromide, Hyoscine butylbromide SCT

Primary outcome

Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
Time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
The maximum measured concentration of hyoscine butylbromide in plasma.
AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
Time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).

2 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
Time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)
Time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Results and safety

Results posted to the registry on 13 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REF-T	28	27
T-REF	28	28

Primary outcome: Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)

Time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter. Geometric mean (Geometric Coefficient of Variation). Unit: picogram (pg)/millilitre (mL)

Measure	Buscopan® (REF) n = 54	Buscapina® (T) n = 55
Value	91 (93.4)	80 (100.6)

Buscopan® (REF) vs Buscapina® (T): Geometric mean ratio (%): T/REF: 87.52 (92.46% CI 77.18 to 99.24)

Population analysed: All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.

Primary outcome: AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)

Measure	Buscopan® (REF) n = 52	Buscapina® (T) n = 55
Value	807 (89.3)	725 (89.1)

Buscopan® (REF) vs Buscapina® (T): Geometric mean ratio (%): T/REF: 91.74 (92.46% CI 83.51 to 100.78)

Population analysed: PK population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first administration of study medication to up to 96 hours of completion of the last period or up to 72 hours after withdrawal/withdrawing from the study (up to 34 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buscopan® (REF)	0 of 56 (0%)	0 of 56 (0%)	Not reported
Buscapina® (T)	0 of 56 (0%)	0 of 56 (0%)	Not reported

Limitations and caveats (from the sponsor): There was a stage 2 planned after stage 1 which was not performed as bioequivalence was concluded after completion of Stage 1.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hyoscine butylbromide in people with Healthy, run by Boehringer Ingelheim at 1 site in Canada.

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 1 inclusion and 1 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 5 Apr 2017. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) (time frame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter). 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 NCT02516098.

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 5 Apr 2017.