Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers
NCT02036775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2015-05-13
Summary
To characterise pharmacokinetics and assess the relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg
Conditions
- Healthy
Interventions
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
- DRUG
-
Lasolvan prolonged-release hard capsule
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan prolonged-release hard capsule
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan prolonged-released capsules
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan tablet
One Lasolvan tablet 30 mg twice daily for 5 days.
- DRUG
-
Lasolvan prolonged-release hard capsule
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
- DRUG
-
Lasolvan prolonged-release hard capsule
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan prolonged-release hard capsule
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
- DRUG
-
Lasolvan effervescent tablet
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2014-05-31
- Completion
- 2014-05-31
Countries
- Russia
Study Locations
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